Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 4.4 - DOCUMENTATION & CR

Table of contents

4.4.1 - AUTHORITY

Section 703 of the FD&C Act [21 U.S.C. 373] describes FDA's authority to access and copy records of interstate shipment.

4.4.2 - OBJECTIVE

For FDA to initiate formal legal action, interstate jurisdiction must be established. Most often, this is done by documenting interstate movement of a product by copying records ("getting the records") of a shipment represented by an Official Sample. However, on occasion, jurisdiction can be fixed on a limited list of articles, e.g., counterfeit drugs, medical devices, oleomargarine, through other means.

4.4.3 - POLICY

Fully document every Official Sample at the time of collection unless instructed otherwise by the program, the assignment or your supervisor. Current agency policy does not require the collection of records of interstate movement for the issuance of a Warning Letter. Also, the FDA Modernization Act expanded the (rebuttable) presumption of interstate commerce for medical devices to all commodities regulated by FDA. Nevertheless, in any situations where you think a formal legal action may occur, make sure you collect copies of interstate records.

The decision to collect copies of records of interstate commerce in situations involving warning letters may be further covered by District policies or situations. As an example, in cases where the records are readily available and the site is located a long distance from an FDA office, it may be better to collect copies of the records at the time the sample is collected. This will ensure FDA has the records in the event a different action is chosen and you will have saved resources in their collection.

4.4.3.1 - Collection Records

Sample Collections are recorded in the Field Accomplishments and Compliance Tracking System (FACTS). Individuals who may be assigned to collect samples should routinely obtain in advance, a supply of FACTS sample numbers, to be used by the collector to identify samples in the field, prior to accessing FACTS to prepare a sample collection record.

4.4.4 - RESPONSIBILITY

Document samples in accordance with procedures in this Subchapter being certain the copies of records obtained cover the product sampled.

Do not remove the dealer's only copy of records. Whenever possible, photocopy or mechanically copy records, if duplicates are not available. Reproductions should be reviewed to ensure all relevant information is readable.

It is possible to enhance the clarity of photocopies from poor originals (e.g., second or third carbon copies, copies in blue ink, etc.) by overlaying the "original" document with one or two clear yellow plastic sheets. These clear yellow plastic sheets are available at most stationery stores.

If the above procedure does not enhance the copied document, pen and ink additions should be made. Records copied on FDA forms must be accurate and legible.

If you are documenting a shipper violation at a dealer, it is your responsibility to show the storage conditions did not contribute to the violation. Obtain an affidavit describing handling of the goods after receipt, and any other information which supports the violation.

In cases where the product does not move Interstate but is formulated from I.S. raw materials, government jurisdiction may be established by documenting the I.S. nature of the major raw materials. This is done by linking copies of records for the I.S. raw material with the production of the final product, by affidavit from a knowledgeable and responsible firm official. See IOM Exhibit 4-7.

Note: In the case of imported products which have been released to commerce, documentation of the sample should also include the port of entry and the importer of record to facilitate investigation by the home district if necessary.

4.4.5 - SAMPLE RECORDS IDENTIFICATION

Identify copies of all records obtained and attached to the collection report (except FDA forms) with the sample number (including the prefix if appropriate), collection date, and collector's handwritten name or initials. See IOM 4.5.2.5. If a document is more than one page in length, it must be numbered or attached in a manner that will always allow further reviewers to determine if any pages are missing. See IOM 5.10.4.3.20.

If the firm maintains their records on film or electronically, see IOM 5.3.8.3.1 and 5.3.8.3.2.

4.4.6 - EVIDENCE REQUIRED

When documenting violative situations, consider whether you have established FDA's jurisdiction, documented interstate commerce, shown a violation, and determined responsibility for the violation. The contemplated legal action determines the extent of documentation. A preponderance of evidence is required to prevail in a civil action, such as a contested seizure, as opposed to a criminal prosecution, which requires evidence establishing guilt beyond a reasonable doubt.

4.4.6.1 - Seizure

For a seizure action, FDA must establish jurisdiction over the product, show its interstate movement and document a violation.

Obtain copies of any document proving the article was introduced into or in interstate commerce, or held for sale after shipment in interstate commerce. Collect copies of the best records available, without extensive search or travel. See section 304(a)(1) of the FD&C Act [21 U.S.C. 334].

4.4.6.2 - Injunction or Criminal Prosecution

The proof required depends on the violation of Section 301 of the FD&C Act [21 U.S.C. 331].

4.4.6.2.1 - Introduction Into Interstate Commerce

Proof is required showing introduction into interstate commerce on or about a certain day by a specific person of a specific consignment of the article. In addition, delivery for introduction into I.S. requires proof the seller had knowledge the purchaser intended to introduce the article into interstate commerce. See Section 301(a) or (d) of the FD&C Act [21 U.S.C. 331 (a) or (d)].

4.4.6.2.2 - Adulteration Or Misbranding In Interstate Commerce

Proof is required showing that a specific consignment was in interstate commerce and was rendered violative by a specific person on or about a certain date while therein. See Section 301(b) of the FD&C Act [21 U.S.C. 331 (b)].

4.4.6.2.3 - Receipt In Interstate Commerce

Proof is required showing receipt of a violative consignment in interstate commerce on or about a certain date, along with evidence to show specific delivery thereafter by a specific person. It is essential to show the violative condition of the shipment was known to the consignee before the delivery or proffered delivery. Whether it was sold or given away is immaterial. See Section 301(c) of the FD&C Act [21 U.S.C. 331 (c)].

4.4.6.2.4 - Manufacture Within A Territory

Proof is required of manufacture within any territory by a specific person on or about a certain date. See Section 301(g) of the FD&C Act [21 U.S.C. 331 (g)].

4.4.6.2.5 - False Guaranty

Proof of the giving on or about a certain date of a specific guaranty and proof of its falsity; usually a specific sale (and delivery) on or about a definite date to the holder of the guaranty. Interstate commerce is not required, except evidence the consignee normally engages in some interstate business. See Section 301(h) of the FD&C Act [21 U.S.C. 331(h)] and 21 CFR 7.13, 201.150 and 701.9.

4.4.6.2.6 - Dealer Violation

Proof of interstate origin of the article, and proof of a specific manipulation which adulterates or misbrands the article, on or about a certain date by a specific person. See FD&C Act Section 301(k) [21 U.S.C. 331 (k)].

4.4.6.3 - Complaint or Injury Samples

Generally samples collected from complainants during investigation of injuries or foodborne out-breaks are investigational in nature and not documented. However, if the nature of the contamination or adulteration is such that regulatory action may be warranted, the interstate nature of the sample should be documented. Affidavits from the consumer, retailer, and wholesaler should be obtained.

At times even though you may not be able to obtain physical portions of the involved item, a Documentary Sample can be collected by photographing the container, contents, labels, codes, etc., and obtaining necessary affidavits and interstate records. See IOM 4.1.6 for sample criteria on complaint samples.

During investigations of alleged tampering incidents, complainants must be advised of the provisions of the Federal Anti-Tampering Act (FATA). A general discussion of the FATA, its provisions for investigation, filing of false reports, and tampering can be useful and informative to those individuals.

Prior to concluding your interview of the complainant, obtain a signed affidavit attesting to the circumstances of the complaint. See IOM 8.8.5.4.

4.4.7 - DOCUMENTING INTERSTATE SHIPMENTS

The minimum set of records ordinarily submitted with a sample will consist of a copy of the invoice covering the sale of the lot to the dealer, the transportation record showing interstate commerce, and an affidavit signed by the dealer, which identifies both the lot sampled and the applicable records. See IOM 4.4.5 and 4.4.7.

Documentation obtained at a location other than the dealer where the sample was collected should be the subject of a memorandum to accompany the collection report.

4.4.7.1 - Sales Records

An invoice does not establish interstate commerce and thus federal jurisdiction. It does not prove actual movement. However, it may provide information as to the value of the goods, carrier, date of shipment, etc. and bear a Food and Drug type guarantee. Collect copies of the invoice to show the owner's intent to sell the product and tie other records to the sample. If the invoice covers numerous items, copy entries covering items sampled and indicate omissions by asterisks. Copy the invoice on the FDA 1662. See IOM Exhibit 4-8. If the invoice bears a Food and Drug guarantee, copy the guarantee on the back of the FDA 1662. Other records which may be substituted in the absence of an invoice are copies of purchase orders, receiving records, canceled checks, correspondence, etc.

Invoices covering in-transit shipments usually are not available. Document any available transportation record that establishes the lot to be in interstate commerce. Be sure to name the shipper and consignee if known. Where positive identification of a shipment cannot be made by personal observation, obtain a statement from the carrier's agent identifying the shipment sampled as having been delivered by the consignor on a certain day for delivery to the consignee. Include in this statement reference to the particular transportation record covering the shipment. The transportation record will generally be available after the shipment is delivered.

Where the sample is taken from a vehicle or dock as the vehicle is loaded, and there are no unusual circumstances which must be explained in a regular affidavit, use the FDA 1664b, Affidavit (In-Transit Sampling).

See IOM Exhibit 4-3.

4.4.7.2 - Transportation Records for Common Carrier Shipments

Section 703 of the FD&C Act [21 USC 373] provides for mandatory access to and copying of all records showing interstate movement of commodities subject to the Act. This is provided the request is in writing, and the records are in the possession of common carriers, or persons receiving or holding such commodities.

Section 704(a) of the FD&C Act [21 USC 374(a)] provides mandatory access, upon presenting your credentials and issuing a written notice of inspection, to documents covering the interstate movement of, non-prescription drugs for human use, prescription drugs and restricted devices. The authority applies to inspection of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs for human use, or restricted devices are manufactured, processed, packed or held.

Note: At times, you may have only the name of the carrier (trucking company), with no address or phone number. If you are unable to locate the trucking company, contact the local office of the U.S. Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA). If you furnish this office the name of the trucking company, they will be able to provide the address and phone number. District DIBs have the phone numbers of local offices of the FMCSA as part of a MOU between DOT and FDA; information can be found as well as on the FMCSA field office contact information website.

4.4.7.2.1 - Refusal To Permit Access To Records In Possession Of Common Carriers

Refusal to permit access to and copying of all records showing interstate movement of articles subject to FDA jurisdiction is unlawful provided the request for such permission is issued in writing. You cannot state that the law requires the records be furnished to FDA unless you also explain it is required only after a written request is issued. If refused, after providing a written request, politely explain the law requires the records to be furnished. You are more likely to get the records through courteous persuasion and tact than through stressing the force of law.

4.4.7.2.2 - Written Request For Records

If a carrier, consignee, or any other person refuses to supply I.S. records, and it is apparent he will not do so without a written request, report the facts to your supervisor. Do not routinely issue a written request for I.S.records since evidence so obtained may not be used in the criminal prosecution of the person from whom obtained.

If the request is being made of a carrier who has no responsibility for the violation, issue a written request only after approval by District Management. When authorized by your supervisor to issue a written request, prepare a statement, using the following guidance, or as otherwise directed by your supervisor:

"Pursuant to Section 703 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 373) permission is hereby requested for access to and copying of all records showing quantity, shipper, and consignee, showing movement in interstate commerce and/ or the holding after interstate movement of___________."

Clearly identify the specific lots which are the subject of the request, the firm and the individual to whom the request is given.

4.4.7.2.3 - Bill Of Lading

The shipper who delivers the goods to the carrier for shipment, prepares The Bill of Lading. It is an order for the carrier to move the goods. When the carrier's agent signs the Bill of Lading he acknowledges receipt for the shipment. The carrier's office in city of origin of shipment maintains a copy of the Bill of Lading. Information normally included is the name and address of shipper, name and address of consignee, date of shipment, name of carrier, vehicle number, and a description of the goods. Copy Bill of Lading on Section II of the FDA 1662. See IOM Exhibit 4-8.

Create a memo to link the carrier’s (e.g., UPS, FedEX, etc.) tracking number document to the actual shipment and delivery documentation and attach to the DOC sample CR with a memo explaining how the records were obtained.

4.4.7.2.4 - Freight Bill

This record is prepared by the transportation company for the purpose of collecting freight charges. It includes the same information found on the Bill of Lading, plus additional data about the carrier's handling of the shipment and cost involved. Railroads prepare Freight Bills at their destination offices, where copies can be made. Steamship and airlines combine the Bill of Lading and Freight Bill into one form. Copies are filed at both origin and destination offices of these carriers. Truck lines prepare Freight Bills at the origin office and both origin and destination offices should have copies. The dealer should have a Freight Bill if he received the goods directly in interstate commerce.

Copy Freight Bills on Section II of the FDA 1662. Enter the type of shipping record in block 21. Section I and II may be executed together on one sheet. If only one section is used, leave the other section blank, and submit the entire page. (See IOM 4.4.7.2.4 and 4.4.7.3 for information on documenting carrier shipment records in CR.)

4.4.7.2.5 - Waybill

The transportation company uses the Waybill in its own operations, and it accompanies the shipment during transit. Copies are not given to the shipper or consignee, but can be obtained from the carrier. Other transportation records are generally more readily available than Waybills. Air Freight Waybill numbers are designed so that the originating line and point of origin are encoded in the Waybill number itself. Each airline has a numerical code description, indicated by the first two digits of the number. The three letters, which next follow indicate the point of origin. For example, Waybill No. 01LGA, designates American Airlines (01) as the carrier, and La Guardia Field (LGA) as the point of origin. Most airline offices have a copy of "Official Air Freight Transmittal Manual", which lists the codes. Other express shipping companies, such as Federal Express, and United Parcel Service have their own codes.

4.4.7.3 - Mail or Parcel Service Shipments.

Always attempt to collect the original wrappings showing cancellation of origin office and address sticker. Record the facts obtained from the dealer on the FDA 463, Affidavit (Parcel Post/Service). See IOM Exhibit 4-9. Before the individual signs the statement he should be asked to affirm the affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit.

To obtain documentation for USPS shipments, ask the dealer where the sample is being collected, to use the shipment label reference number to print the shipping documents from https://www.usps.comdisclaimer icon. If the article was shipped with Express Mail®, point-by-point tracking details are available. To obtain documentation for parcel service (e.g., UPS and Federal Express) shipments, ask the dealer to use the “tracking number” to print the shipping documents from the parcel service’s web-site. Prepare form FDA 463a.

If the shipment is not recent, the dealers may not have access to the records through their accounts. In this case, a visit must be made to a major parcel service/ parcel post office to obtain documentation. See IOM 4.4.7.2.2 and 4.4.7.2.3.

4.4.7.4 - Shipment by Privately-Owned Conveyance

Obtain on the FDA 463a, Affidavit, a dealer's statement setting forth the facts, including the date and manner of receipt. The affidavit by the dealer may not be evidence, since the dealer lacks personal knowledge of the point of origin. Ascertain the name and home address of the driver of the conveyance, vehicle license number, the name and address of the driver's employer or the owner of the conveyance and the driver's license number. Obtain an Affidavit, from the driver setting forth the facts of the shipment. See IOM Exhibit 4-10.

4.4.7.5 - In-Transit Sampling Affidavit

See IOM 4.1.4.3 and 4.3.4.3 for definition and sampling procedures. When obtaining samples from in-transit lots, if it is a straightforward uncomplicated sample requiring no unusual explanations, use the FDA 1664b, Affidavit (In-Transit Sampling). See IOM Exhibit 4-3. Otherwise, use the regular Affidavit, FDA 463a.

4.4.8 - AFFIDAVITS

Statements on various affidavit forms may be obtained from persons who have dealt somehow with the goods sampled, know material facts relating to the movement of the goods, and/or to events affecting their condition. Such facts, recorded in writing and signed by the person who can testify in court to those facts, can be used either to establish federal jurisdiction or fix the responsibility for a violation. The statement may identify documents proving I.S. movement of goods sampled; it may name the person who could testify to the identity of the goods sampled, and it may certify the sample collected is from the lot of goods covered by the records.

4.4.8.1 - General Considerations for all Affidavits

You should have the affiant read the statement and make necessary corrections before signing the affidavit. Mistakes, corrected and initialed by the affiant are an indication he/she has read and understood the statement. A handwritten statement by the affiant, declaring he/she read and understood the statement is a valuable tool to counter the possibility the affiant might later claim ignorance of what was signed.

Before the individual signs the statement, ask him/her to affirm the affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. See IOM Exhibit 4-11.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Subscribed and sworn to before me at ***" Subscribed, in this context means to attest by signing. Thus, your signature is attesting to the fact that the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. If you provide a copy of the affidavit to the affiant, you should keep the original affidavit since the original is an official FDA document.

In cases where the affiant does not speak English, prepare the affidavit on the appropriate affidavit form. Prepare a second affidavit in the affiant’s native language. Having a translator present is necessary to explain the statement and assist in discussion. The affiant will only sign the translated version as that would be the one they can attest to. The two affidavits should be held together. An explanation should accompany as to why the translation was necessary and who prepared the translation (qualification).

4.4.8.2 - Refusal to Sign the Affidavit

Prepare the statement as described above even if it is apparent the affiant will refuse to sign the affidavit. Have the affiant read the affidavit. If they decline, read it to them. Request the affiant correct and initial any errors in his/her own handwriting. Ask the affiant if the statement is true and correct. Ask him/her to write at the bottom of the statement "I have read this statement and it is true, but I am not signing it because..." in his/her own handwriting.

If the affiant still does not sign the affidavit, you should write a statement noting the refusal situation. Write this near the bottom and within the body of the affidavit. Include the actual situation, such as, you recorded the above facts as the affiant revealed them, the affiant read or refused to read the statement and avowed the statement to be true, and the affiant's reason for refusing to sign (e.g., "upon advice of corporate counsel", "per corporate policy", etc.). Sign and date this statement in the body of the document; only sign in the signature block if the affiant signs the affidavit.

4.4.8.3 - Confidential Informants

You should take special precautions when obtaining an affidavit from a confidential informant. The affiant may be reluctant to sign a statement, which reveals his or her identity. See IOM 5.2.9 for guidance on interviewing confidential informants.

4.4.8.4 - Affidavit (Dealer/Warehouseman)

The Affidavit (Dealer/Warehouseman), FDA 1664, is used to document the dealer or warehouseman identification of the lot and related records. See IOM Exhibit 4-12.

Fill in all blanks on the form as applicable. There are sufficient blanks for listing up to three invoices and up to three shipping records covering the lot in question. Any unused blanks should be lined out, and strike out the words or letters in parentheses which are not applicable.

Be certain the dealer knows what he is signing. Before the individual signs the statement, he/she should be asked to affirm the affidavit is true and accurate.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Subscribed and sworn to before me at ***" Subscribed, in this context means to attest by signing. Thus, your signature is attesting to the fact the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. Also see IOM 4.4.8.5 for conditions not amenable to use of the FDA 1664.

4.4.8.5 - Affidavit (FDA 463a)

Unusual sampling situations may present circumstances that do not lend themselves to presentation on the FDA 1664 or 1664b. In these situations, record the facts on an FDA 463a, Affidavit.

There is no prescribed format for composing the statement. However, you should positively identify the affiant by name, title, and address at the beginning of the statement and show why he/she is qualified to make the statement. The facts should be arranged in an order roughly paralleling that of the FDA 1664. The most manageable narrative describes the events and circumstances chronologically. Whatever format is used, the recorded facts must be intelligible to the reader unfamiliar with the transaction. See IOM Exhibit 4-7, 4-10, 4-11, and 4-13.

Ascertain all the facts and record those which are material, relevant, and to which the affiant can affirm.

Narrate the facts in the words of the affiant, using the first person singular. Do not use stilted terms such as, "that" as in the expression "that I am the president of..." If the statement is long and complex, break it down into logical paragraphs.

Have the affiant read the statement and make necessary corrections before signing the affidavit. Mistakes that have been corrected and initialed affiant are an indication he/she has read and understood the statement. A handwritten statement by the affiant declaring he/she read and understood the statement is a tool to counter the possibility the affiant might later claim ignorance of what was signed.

Before the individual signs the statement, he/she should be asked to affirm the affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. Only sign in the signature block if the affiant signs the affidavit. See IOM Exhibit 4-11.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Sub-scribed and sworn to before me at ***" Subscribed, in this context means to attest by signing. Thus, your signature is attesting to the fact that the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. You and the affiant should sign all pages of a multi-page affidavit.

4.4.8.6 - Affidavit (Jobber)

Form FDA 1664a is used to document movement of goods from a jobber to a dealer. See IOM Exhibit 4-14. Complete all blanks as applicable. There are sufficient blanks to list up to three invoices and three shipping records. Line out any unused blanks and strike out all words and letters in parentheses, which are not applicable.

Be sure the jobber knows what he/she is signing. Before the individual signs, he/she should be asked to affirm the affidavit is true and accurate. A statement to that effect can also be added at the conclusion of the affidavit. Only sign in the signature block if the affiant signs the affidavit. See IOM Exhibit 4-11.

You should only sign the affidavit AFTER the affiant has signed it. The wording above your signature is, "Subscribed and sworn to before me at ***" Subscribed, in this context means to attest by signing. Thus, your signature is attesting to the fact that the affiant has read and understood the statement and has confirmed that the statement is the truth. You MUST NOT sign an affidavit until after the affiant swears (affirms) to you the written statement he/she has signed is true. The dealer may be provided a copy of an affidavit if he/she requests it.

4.4.9 - LABELS AND LABELING

No sample documentation is complete without copies of the label and labeling. No special effort is needed to obtain copies of the label when it is on the individual units collected. However, the goods may be accompanied by labeling which is not affixed to the product. In this case, you must obtain copies of all labeling. Although your sample assignment may not specifically request the collection of accompanying labeling, determine if such labeling exists, and if it is present, collect it.

Collect copies of all labeling as directed by your assignment or Compliance Program (CP), when you are collecting labeling specifically to document labeling violations; otherwise, one copy is sufficient for routine review. The CP may require the collection of additional copies so that various offices can review the labeling simultaneously. Be sure to review the CP to ensure you collect enough original copies of labeling. Scan or mount as appropriate, individual copies of labeling so they can be reviewed by various individuals located in separate offices. If the labeling design prohibits effective scanning, multiple copies of the labeling may be necessary. Do not collect the actual labeling if only one copy is available. To do so may remove the offending literature and thus correct the misbranding or you may misbrand the product yourself, by removing legally mandated information. Photographs or other copies must be made in this case.

4.4.9.1 - Labels & Accompanying Labeling

These are defined as:

  1. Label - A display of written, printed, or graphic matter upon the immediate container of an article.
  2. Labeling - All labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. Labeling includes such material as circulars, booklets, placards, displays, window streamers, books, article reprints, etc., that supplement or explain a product and /or are part of an integrated distribution system for the product. If the labeling and the product are in functional proximity at a point of sale, provide diagrams or photographs of this relationship. If the labeling and the product are found at a manufacturer or distributor, document the role that the labeling will play in the distribution of the product (e.g. to whom will it be sent and when).

Dealer Identification - Request the dealer (Note: a manufacturer may be considered a dealer if the product being sampled is located at the manufacturer) identify collected copies of accompanying labeling with his initials and the date. This will identify these copies of labeling if they are introduced in court later. Prepare a dealer's affidavit on the FDA 463a, covering the relationship of the labeling to the goods. This affidavit should include the following information.

  1. Description of Labeling - Describe briefly each piece of literature by name of identifiable quote, i.e., Leaflet, "Do You Have Tired Blood" or Window Streamer, "Amazing New Tranquilizer". State the quantity of such labeling on hand.
  2. Location of Labeling - Report the location of each different piece of literature and how much of each is at that location.
  3. Method of Distribution - Determine how the labeling is made available to the public. Describe how it is displayed such as: for voluntary pick-up; mailed to prospective customers; distributed without being displayed, etc.
  4. Source of Labeling - Describe whether the labeling was sent to the dealer by the shipper of the goods or if the dealer prepared the labeling himself or if it originated from another source. It is important to document this point to fix responsibility in the event the agency wishes to pursue action against that individual. It is not necessary to determine or fix responsibility in order to seize the goods. Document the shipment of the labeling if a source other than the dealer supplied the labeling.
  5. Instructions to Dealer - The manufacturer or shipper often provide sales promotion instructions to the dealer. Obtain copies of such instructions if available.

4.4.9.2 - Bulk Shipments

Do not remove the label from bulk containers such as drums, barrels, and large bags, if this results in misbranding the article. Remove and submit an identical label from an empty container if available. Photograph or trace the label if none other is available.

Note: Besides using tracing paper, it is possible to trace a label on a piece of plastic, similar to a document protector, using either a ball point pen or stylus. If it is difficult to read, filling in the tracing with a marker, may highlight the tracing.

4.4.9.3 - Unlabeled or Partially Labeled Lot

The regulations provide for controlled shipment in IS commerce of unlabeled goods. It is a violation to ship unlabeled goods unless:

  1. The shipper operates the establishment where the article is to be processed, labeled or repacked, or
  2. If the shipper is not the operator of the establishment, he must first obtain from the owner a written agreement signed by the operator. The agreement must contain the post office addresses of both parties and describe the specifications and the processing, labeling, or repacking procedures, in sufficient detail to insure that the article will not be adulterated or misbranded within the meaning of the Act, upon completion of the processing, labeling or repacking.

Determine if there is a labeling agreement and obtain copies of pertinent correspondence. See 21 CFR 101.100, 201.150, and 701.9.

4.4.9.3.1 - Documentation

Collect both unlabeled and relabeled units or specimens of the label to be affixed. Collect specimens of any shipping case labels and any labeling which accompanied the original shipment.

Obtain evidence showing how the lot was labeled at the time of receipt; how the misbranding occurred, and who was responsible. Use photographs and diagrams if necessary to portray the present condition of the lot. If any of the lot has been resold, collect documentary evidence of the resale.

4.4.10 - REPORTING SAMPLE COLLECTIONS

See IOM 1.1 English language requirement. For each sample collected prepare a FACTS Sample Collection Record. Remember the collection report is the basis for most administrative and regulatory actions. The data entered into specific fields of the report are intended to provide information for the compliance officer to prepare documents for legal proceedings. While there may be more than one right way to describe the specific circumstances you are documenting, it is important to keep in mind the subsequent readers of your collection report. See IOM Exhibits 4-1, 4-2, 4-15, and 4-16 for examples. Sample collection data may be entered either from an FDA office or from a remote location in the field using a laptop computer and modem. If change is needed to the data in the FACTS Firms table relating to the sample collection, e.g., the firm's name or address has changed; you (the collector) should notify your district's OEI coordinator, so the information can be updated in the FACTS firm table.

After collection data is entered into the FACTS system, you (the collector) must check the record for accuracy and completeness, send it to a supervisor for review, if appropriate, and then sign it electronically. The original data will be stored and permanently associated with this record. Any future changes to the FACTS database reference tables, such as the firm files, employee name, data codes, etc., will not alter the original data in the electronically-signed sample collection record.

Only the collector has editing privileges for the signed original sample collection record. You may modify the original record but must electronically sign each revision. All modifications of the original record are permanently retained as part of the original record. A permanent electronic record trail is created, capturing and retaining every change to original and subsequent records. If re-trieval of the sample collection data is needed, the original record and all changes to the original record can be retrieved.

4.4.10.1 - FlagHighlighted to denote updated text

The following situations require an entry in the Sample Flags screen in FACTS. See IOM Exhibit 4-15.

4.4.10.1.1 - 301(K) Sample

"301(k) Sample " - See IOM 4.1.4.4.

4.4.10.1.2 - Complaint Sample

Use this flag for any sample collected from a complainant during follow-up investigation.

4.4.10.1.3 - Dealer Voluntarily Holding

This flag alerts the reviewer the lot is being voluntarily held. Enter how long in the Flag Remarks field. This information will be important for the compliance officer to know when preparing a seizure or other regulatory action.

4.4.10.1.4 - Exhibit Sample

When sample is to be used exclusively for court exhibit without analysis.

4.4.10.1.5 - Factory Food Sample

Flag as "Factory Food Sample" when sample(s) of any item, used in the production of any food product, are taken during the EI. See IOM 4.1.6.

4.4.10.1.6 - Fumigated

Enter name of fumigant in Flag Remarks field.

4.4.10.1.7 - Inv. Samples Of Filth ExhibitsHighlighted to denote updated text

Enter the product code of the filth exhibits (obtained from the Data Codes Manual) in the Product Code field of the FACTS Sample Collection Screen. Note the product code for exhibits consists of the Industry Code followed by "YY-99" or "Y--99" as below.

Example: Filth Exhibits of gnawings, pellets, wood splinters, etc.

In a food plant = 52YY-99
52 = Misc. food related items
Y = Exhibits
Y = Sub class - None
- = Dash
99 = Evidence exhibits n.e.c.

In a drug plant = 66Y--99
66 = Misc. drug related
Y = Exhibits
- = Dash
- = Dash
99 = Evidence exhibits n.e.c.

Other industries: Handled in same manner using applicable industry code(s).Highlighted to denote updated text

4.4.10.1.8 - Pesticide Sample

After flagging a pesticide sample, the basis for sampling must be entered in the Flag Remarks field as either "Pesticide Compliance" or "Pesticide Surveillance". Additionally, the name of the county and state, or country where grown must be entered in the appropriate fields in the Collection Record.

Pesticide Episode - An "episode" is defined as a violative pesticide (or other chemical contaminant) finding and all samples collected in follow-up to that finding. All samples must be associated with one responsible firm (grower, pesticide applicator, etc.) and one specific time period (e.g. growing season). The following examples are provided for clarification of this definition:

  1. Samples of cantaloupes from Mexico reveal violative residues. Any destination point samples or subsequent compliance samples from the same shipper or grower would along with the original sample be considered an episode.
  2. Grower Jones has violative residues of chlorothalonil on collards for which there is no tolerance. Field samples, I.S. samples, and packing shed or warehouse samples of these collards would all be part of the same episode.
  3. Grower Jones also has violative residues of omethoate on kohlrabi about two months later. This is a separate episode.
  4. Along with the omethoate on kohlrabi, Grower Jones has violative residues of omethoate on beets. Normally this would be considered a separate episode from the previous episode. However, if information were available showing that both residues resulted from the same application of the pesticide or the residues were closely related in some other way, the beets might be considered as part of the kohlrabi episode.
  5. Grower Smith has violative residues of disulfon and permethrin on kale. This would be considered as one episode because only one commodity is involved.

Note: The detention without physical examination procedures provide for recommending detention based on a single violative pesticide finding. See RPM Chapter 9-6. Under these procedures we may anticipate that the number of compliance samples collected in follow-up to a violative finding may diminish appreciably and, in most cases, will be limited to occasional audit samples. These samples should also be linked to the sample number (episode number) of the original violative sample that prompted the automatic detention. This episode number will be indicated in the applicable Import Alert.

The Episode Number will be the sample number of the first violative sample collected in a series of samples and is used to identify the other related samples within an episode. The district must assure that the Episode Number is used within the district and any other districts which follow-up to the original violative sample. This number must appear in the Episode Number field of the FACTS CR.

4.4.10.1.9 - Reconditioned

When collected in connection with a reconditioning operation in accordance with a court order.

4.4.10.1.10 - Sampled In Transit

Use when the sample is collected from a carrier or while in transit. Indicate this flag in the Collection Remarks field. See IOM 4.1.4.3 and 4.3.4.

4.4.10.1.11 - Split Sample

Use this flag when a sample is divided between two or more laboratories.

4.4.10.1.12 - Survey Sample

Use this flag for any sample collected under a Compliance Program, which directs samples be collected as part of a survey, or if an assignment to collect the sample(s) indicates the sample(s) are "Survey" sample(s). Use this flag for any sample collected under the Drug Surveillance Program (CPGM 7356.008); enter the survey number in the flag remarks section.

4.4.10.1.13 - Under State Embargo

This flag alerts the compliance officer that the lot is being held under state embargo. Enter how long in the Flag Remarks field.

4.4.10.2 - Type Identification

When applicable, using the list of values, choose one of the following to complete the Sample Type field in FACTS. Identify any documents associated with the sample, and the sample itself, with the corresponding prefix, if noted followed by the FACTS sample number.

4.4.10.2.1 - Additional (ADD)

To identify a physical sample collected from a previously sampled lot. Do not report or document as an "ADD Sample" those instances when only additional records or documentation are obtained for the sample.

4.4.10.2.2 - Audit/Certification

To identify a physical sample collected to verify analytical results provided by a certificate of analysis or private laboratory analysis that purports to show the product complies with the Food, Drug and Cosmetic Act.

4.4.10.2.3 - Documentary (DOC)

To identify an official sample comprised of documents and photographs, collected without a physical portion. Do not use this designation to identify a physical sample for which you wish to delay analysis. See IOM 4.1.4.2and Exhibits 4-1 and 4-2.

4.4.10.2.4 - Domestic Import (DI)

To identify samples collected of foreign products, which have passed through Customs and entered domestic commerce. The country of origin must be reported on the C/R. See IOM 4.1.4.8.

4.4.10.2.5 - Food Standards (FS)

To identify samples collected to provide information on which to base Food Standards. See IOM 4.1.5.

4.4.10.2.6 - Investigational (INV)

To identify samples collected to document observations and/or where interstate commerce does not exist or is not necessary. See IOM 4.1.6.

4.4.10.2.7 - Mail Entry

To identify a sample of an imported product that entered the United States through the U.S. Mail.

4.4.10.2.8 - Non-Regulatory

To identify a sample collected and analyzed by FDA for other federal, state or local agencies of products over which FDA has no jurisdiction.

4.4.10.2.9 - Official

To identify a sample which is representative of a lot of any product covered by the Food, Drug and Cosmetic Act for which interstate commerce can be documented.

4.4.10.2.10 - Post Seizure (PS)

To identify samples collected pursuant to a court order from a lot under seizure. See IOM 4.1.4.7.

4.4.10.2.11 - Regulatory

A sample collected or analyzed by non-FDA personnel, including samples submitted by industry.

4.4.10.3 - Preparation

The collection record (C/R) is the starting point and the basic reference for all actions and considerations based on the sample. It contains or bears direct reference to every important point about the sample and the lot from which it was collected. See IOM Exhibits 4-1, 4-2, 4-15, and 4-16 for examples.

Individual Fields - Complete the individual fields on the FACTS Sample Collection Screen as indicated. The following fields must be completed to save the sample information; Sample Class; Sampling District; Collector; Collection Date; Sample Basis; Sample Type; FIS Sample Number; Sample Description; Product Code; Product Description; Resp. Firm Type; Resp. Firm FEI Number; PAC; Sample Origin; and CR and Records Sent To. The fields described below are listed in alphabetical order to facilitate locating the instructions. Please note, when a collection report is generated, the field names may change on the report.

Any information that needs to be included regarding the sample and that cannot be documented via FACTS, should be documented on the C/R Continuation Sheet, FDA 464a. For example, pictorial descriptions of a field exam for a filth sample; or a description of relative documents and what they demonstrate regarding the subject lot of a documentary sample; etc.

4.4.10.3.1 - Accomplishment Hours

Enter the accomplishment data for every sample collected, by clicking on the "clock" icon at the FACTS task bar. In the Accomplishment hours screen, enter the PAC by selecting from the list of values and type in the number of hours spent collecting the sample. Also enter all PACs that were entered in the Collections PACs field on page 2 of the collection record. If another person is involved in the collection, add their time by clicking on the "Add" button. See IOM exhibit 4-16 page 2.

4.4.10.3.2 - Analytical Assignment

After saving a collection record, the system will prompt you for analytical assignment data. Enter lab analysis data (PAC and PAF) for your sample. The analytical PAC and PAF (Problem Area Flag) may be different from the collection PAC and PAF. Enter split sample data on separate lines. For DOC samples leave this field blank. Do not enter any data in this form if the sample is being delivered to a non-FACTS lab.

4.4.10.3.3 - Brand Name

Enter the Brand Name of the product. This is found on the labeling of the product. It is important to identify the product completely so the compliance officer can communicate accurate information to the court and the U.S. Marshal in the event of a seizure.

4.4.10.3.4 - Carrier Name

Enter name of the transportation company who transported the goods in interstate commerce if known at the time of preparation of the CR. You may need to obtain this later to fully document interstate commerce. In the case of a 301(k) sample, this is the transportation company who moved the component you are documenting across state lines. For a 301(a) sample documenting the shipment of a violative product in interstate commerce, enter the name of the carrier utilized by the manufacturer or distributor to carry the goods across state lines.

4.4.10.3.5 - Collection Date

Enter the date using the format - mm/dd/yyyy. Note: the default date is today's date. Be careful not to use the default date if the sample was not collected on the date the CR is created. Only one date can be entered; if the sample collection was accomplished over several days, use one date. Be consistent. This date should be used to identify the physical sample and any records attached to the CR. This field is critical; be certain to verify the date.

4.4.10.3.6 - Collection Method

Describe how you collected the sample and which subs are the 702(b) portion. Relate the number and size of the sampled units and subsamples to show how each was taken, e.g., "Two cans of product randomly collected from each of 12 previously unopened cases selected at random." Note any special sampling techniques used, e.g.: "Subs collected using aseptic technique and placed in sterile glass jars or whirl-packs" or "Subs 1-10 consist of approx. 1# of product. Subsamples 1-10 collected from bulk storage Bin #1 composited in unused, brown, paper bag." Completely describe the collection method of each sub of selective samples with multiple subsamples, including your observations of the conditions, e.g.: “Two live insects collected from seam of bag #2. Live insects were observed exiting bag and two were collected upon exit.” You will normally need to use a continuation sheet to describe collection of all subsamples and your description of the lot “bag-by-bag” examination. See IOM 4.5.2.1 regarding sub identification.

4.4.10.3.7 - Collection Pacs

Enter the Program Assignment Code (PAC), which is most correct, from the list of values. If the PAC on your assignment is not listed, discuss with your supervisor or FACTS Lead User.

4.4.10.3.8 - Collection Reason

Enter the complete reason for collection giving the suspected violation, compliance program guidance manual, and analysis desired. Identify any interdistrict, regional, headquarters initiated, assignment document(s) in sufficient detail so the document can be located, if necessary. If the sample was collected during an inspection to document violations found, state that and indicate the date of inspection. See IOM exhibits 4-1 and 4-16.

4.4.10.3.9 - Collection RemarksHighlighted to denote updated text

Enter any remarks you feel are necessary. Describe any special circumstances. If a 704(d) [21 U.S.C. 374(d)] letter is indicated, include the name, title, E-mail address (if available) and the telephone/fax number of the most responsible person at the firm to which the letter should be addressed.Highlighted to denote updated text If the sample is an in-transit sample, state the sample was collected in-transit, from whom sampled (e.g. driver and carrier firm), and where sampled. If the dealer firm is a consumer, the name and address of the consumer should be entered in the Collection Remarks field, and the consumer's state in the State field. You may use a "CR Continuation Sheet", FDA 464a if you need more space.

Note: Confirmation of firm Email address and inclusion in collection remarks is integral in order to provide results in an efficient and timely manner. According to Field Management Directive (FMD) 147, if the firm has agreed to hold products pending FDA results or if the analytical results are laboratory classification 3, the Laboratory Director or their designee shall email the results of analysis to the collecting district's established email account for receipt of analytical results.Highlighted to denote updated text

4.4.10.3.10 - Collector

Your name should appear here by default.

4.4.10.3.11 - Collector's Id On Package/Document

As the Sample Collector, quote your identification placed on the packages, labels, etc., e.g., "55563 12/5/05 SAR". See IOM 4.5.2.3. When multiple units are collected, all or at least a portion should be labeled as subsamples. Subsample numbers need to be included on the C/R and in the EIR. You may include the sub numbers used in this block outside of the quotes, e.g., "55563 12/5/05 SAR" subs 1-30.

4.4.10.3.12 - Collector's Id On Seal

Quote your identification used on the Official Seal applied to the sample, e.g., "55563 12/5/05 Sylvia A. Rogers". See IOM 4.5.4.1and exhibit 4-17. If you use the FDA metal seal, enter the words "Metal Seal" followed by the seal identification and number, e.g., "U.S. Food and Drug 233", entering the actual number of the seal used. Samples need to be kept under lock or in your possession, until sealed. The Collection Remarks field needs to describe any discrepancy between the date sealed and the date collected. Normally, the sample should be sealed on the same day as collected.

4.4.10.3.13 - Consumer Complaint Number

If the sample relates to a consumer complaint, enter the complaint number. This will allow your CR to be linked to the complaint and viewed by the Consumer Complaint Coordinator and other District and Center personnel.

4.4.10.3.14 - Country Of Origin

Select the Country of Origin, if known. This field is of particular need when the sample is a Domestic Import Sample.

4.4.10.3.15 - County

Select the County where the sample was collected (or grown if appropriate, i.e. a pesticide sample of an agricultural product.) This field is not needed for many samples. Use for pesticide samples to aid in later communication with State officials in the event of a violative result.

4.4.10.3.16 - Cr & Records Sent To

Enter the division or district office to which you will send the CR and records. This should be the office which is most likely to initiate any regulatory action. This field requires some thought on the part of the collector and communication with the supervisor. For a 301(k) sample, where the dealer is responsible, this is the district where the sample was collected. Do not assume the address on the label is the location where follow-up to a violative sample will be initiated. Do not send the records to another district unless you know it is the district of the actual responsible firm. Per Staff Manual Guide f 2460.2, Field Office Filing System (or f:3291.2 as listed on the FDA internet site), field survey samples will be filed by the collecting district.

4.4.10.3.17 - CRX/DEA Schedule

Choose the appropriate schedule from the list of values, if applicable.

4.4.10.3.18 - Dairy Permit Number

Enter if applicable. If you are collecting samples from a dairy, obtain this number from the firm.

4.4.10.3.19 - Date Collected

See Collection Date IOM 4.4.10.3.5.

4.4.10.3.20 - Date Shipped

Enter date in the format, mm/dd/yyyy. This is the date of interstate shipment. Obtain it from the documentation you collected to document interstate movement of the product. Identify the document you used to determine this date in the “Documents Obtained” section.

4.4.10.3.21 - Documents Obtained

Click on the "Documents Obtained" button to enter Document Type, Document Number, Document Date and Remarks for any records collected to support a violation or show interstate movement of the product sampled. Enter an identifying number and date for invoices, freight bills, bills of lading, etc. Include the name and title of person signing any affidavits in the Remarks field. Be sure to describe the reason each document attached to the collection record was obtained. For example, when referring to a bill of lading, indicate that it was collected to document the interstate movement of the product. Also indicate which documents were collected to document specific violations encountered during inspections. State the number of pages for each document if it contains more than one page and refer the reader to the appropriate section/page of the document which shows the deviation you are documenting. Indicate the number of photographs attached. Depending on the sample and what you are trying to document, you may use the document number to record the actual number of the document (i.e., invoice number or bill of lading number) or to order the documents attached. You should order your documents in a manner that allows easy review (be guided by your supervisor or Compliance Branch) and attach the documents to the printed C/R in the order they were entered into FACTS. This section may also be used to list C/R attachments including FDA generated forms. See IOM exhibit 4-1.

4.4.10.3.22 - Episode Number

Enter an episode number if applicable. See IOM 4.4.10.1.8.

4.4.10.3.23 - Estimated Value

Enter the estimated wholesale value of the lot remaining after sampling. Obtain this information from invoice or other records. (This is not the value to be used for seizure bond purposes; however, it may be used by the district to evaluate whether seizure is an appropriate action.) Estimate value if you have no documentary reference. For DOC samples (see Exhibits 4-1 and 4-2,), indicate the estimated value of the lot. If the DOC sample is collected to document a lot that has already been shipped, estimate the value, or obtain a figure from your documentation, which represents what was shipped. Many times a DOC sample is collected merely to establish interstate commerce, in those situations, the value of the goods that traveled, or will travel, in interstate commerce is what is needed.

4.4.10.3.24 - FEI Number

The FEI number is a 10-digit unique identifier, which is used to identify firms associated with FDA regulated products. Use the Build button to query the database and find an FEI for firms associated with your sample. If one does not exist, FACTS will assign one to the firm. Take care in entering search criteria to avoid creating unnecessary FEI numbers. You must enter an FEI for a dealer on every CR, unless you check the box indicating the dealer is a consumer.

4.4.10.3.25 - Firm Name

This will be filled in by FACTS when you select an FEI.

4.4.10.3.26 - Firm Type

Using the list of values, select one of the following for each FEI entered, with respect to the product sampled:

4.4.10.3.26.1 - Dealer

This is always the firm from which the sample was collected. There must be a dealer entered on every CR, unless you check the box indicating the dealer is a consumer. Note: this is not the same as the establishment type of the firm identified by the FEI. There are circumstances where you may identify the same firm as the dealer and another establishment type, such as when collecting a plant in-line sample.

Note: If the dealer firm is a consumer, the name and address of the consumer should be entered in the Collection Remarks field, and the consumer's state in the State field. When the sample is an in-transit sample (see IOM 4.1.4.3), enter the consignee of the lot as the dealer and state in collection remarks the sample was collected in-transit, from whom sampled (e.g. driver and carrier firm), and where sampled.

4.4.10.3.26.2 - Grower

Select "Grower" if the FEI identifies a producer of a raw agricultural commodity.

4.4.10.3.26.3 - Harvester

Use "Harvester" for an FEI identifying the harvester of the product sampled.

4.4.10.3.26.4 - Ingredient Supplier

"Ingredient Supplier" should be used to identify a firm which supplied a raw material or component. For example, when documenting a 301(k) [21 U.S.C. 331(k)] situation.

4.4.10.3.26.5 - Manufacturer

Use "Manufacturer" with an FEI, which identifies the manufacturer of the product sampled. Note: this may be the same as the dealer when a product is sampled at a manufacturer. In that case, you can enter the FEI twice and identify it as both the manufacturer and the dealer.

4.4.10.3.26.6 - Shipper

The shipper is the firm responsible for causing the interstate movement of the product.

4.4.10.3.27 - FIS Sample Number

Enter the last two digits of the fiscal year. The remainder of the number will be assigned by FACTS. Note: FIS sample numbers will no longer be required when the FIS is turned off.

4.4.10.3.28 - Food Canning Establishment

Enter "Food Canning Establishment" if applicable.

4.4.10.3.29 - Hours

See Accomplishment Hours in IOM 4.4.10.3.1.

4.4.10.3.30 - How Prepared

Explain how the sample was prepared prior to submission to the laboratory; how you identified some or all the units; and how you wrapped and sealed the sample. Note any special preparation methods such as fumigation, frozen, kept under refrigeration, etc, and the form in which the sample was delivered to the laboratory, e.g. in paper bags, original carton, etc. If coolants or dry ice were used, indicate so here. It is important to be specific as to how you protected the integrity of the sample and the chain of custody, e.g., “Subs identified as noted (describe how 702(b) portion was prepared/handled- see IOM 4.5.2.1), placed in unused, brown paper bag; bag taped shut and FDA seal completed (as noted) and applied, bag identified as noted in pen/ink. FDA 525 attached to sealed bag, placed in brown, cardboard box and prepared for shipment, then delivered to district security guard desk for UPS pick-up."

4.4.10.3.31 - Lot Size

Enter the amount of goods on hand before sampling as determined by your inventory of the lot. Include the number of shipping cases and the size of the components, e.g., 75 (48/12 oz.) cases, 250/100 lb. burlap bags, 4/100,000 tab drums, 24 cases containing 48/12/3 oz. tins. If accompanying literature is involved, describe and state the amount on hand. For DOC samples (see Exhibit 4-1 and 4-2), also indicate the lot size, e.g. "one x-ray machine" or "50000 syringes and 1000 promotional brochures."

4.4.10.3.32 - Manufacturing Codes

Click on the "Manufacturing Codes" button to enter and identify all codes, lot numbers, batch control codes, etc., and how they are displayed on labels, cartons and shipping containers. Enclose the code in quotes, e.g. "code". For example, code embossed on can cover, "87657888" or code applied in ink on side of carton, "0987878". Also indicate the manufacturing codes used on products for which a DOC sample was collected, for example, "serial number "ABC" stamped on metal plate." See IOM Exhibit 4-2.

Enter any expiration dates in the Exp. Date field.

4.4.10.3.33 - Method Of Collection

See Collection Method in IOM 4.4.10.3.6.

4.4.10.3.34 - National Drug Code

Enter if applicable

4.4.10.3.35 - Orig CR & Records To

See CR and Records Sent To in IOM 4.4.10.3.16.

4.4.10.3.36 - Payment Method

Select one of the following from the from the list of values: "Billed"; "Borrowed"; "Cash"; "Credit Card"; "No Charge"; "Voucher". The “Credit Card” option means you used your personal credit card as a last resort.

4.4.10.3.37 - Permit Number

See Dairy Permit Number in IOM 4.4.10.3.18.

4.4.10.3.38 - Product CodeHighlighted to denote updated text

Enter the 7-digit product code. Use the product code builder for guidance.Highlighted to denote updated text When 301(k) samples are collected, the full product code of the finished product must be entered. See IOM exhibit 4-1. See IOM 4.4.10.1.7 for product codes for filth or evidence exhibits.

4.4.10.3.39 - Product Description

Enter a complete description of the product including the common or usual name and the product packaging/container system. For example, aspirin tablets packed in clear, non-flexible plastic bottle with white screw on top with yellow stick-on label and black printing. Bottles packed in white, paperboard boxes with black printing. Paperboard boxes packed in brown cardboard boxes with black printing. If you need additional space, continue the description in remarks. See IOM exhibit 4-1.

4.4.10.3.40 - Product Label

Quote pertinent portions of the label such as brand name, generic name, quantity of contents, name and address of manufacturer or distributor, code, etc. In the case of drugs, quote the potency, active ingredients and indicate whether Rx or non-Rx. Quote sufficiently from accompanying literature to identify. In the case of a Documentary Sample, sufficiently describe the article to identify what is sampled.

NOTE: When the product sampled is packaged in a carton, shipping case or similar container, quote the pertinent labeling from the container.

When quoting from a label, or labeling, use exact spelling, capitalization, punctuation, arrangement, etc., as found on the original label(ing). Use asterisks to indicate any omissions.

4.4.10.3.41 - Product Name

Product Name field is completed by FACTS when you select the product code.

4.4.10.3.42 - Reason For Collection

See Collection Reason in IOM 4.4.10.3.8.

4.4.10.3.43 - Recall Number

If the sample was collected as part of a recall investigation where the recall number is already known, enter the recall number.

4.4.10.3.44 - Receipt Issued

Select "FDA472", "FDA484", or "None" from the list of values.

4.4.10.3.45 - Receipt Type

See Receipt Issued in IOM 4.4.10.3.44.

4.4.10.3.46 - Related Samples

This field is used to identify a sample number to which other sample information can be linked. When you collect more than one sample from a single shipment or there is more than one sample relating to a possible regulatory action, designate one sample as the "lead" sample. Enter that sample number in this field of the collection record for each related sample. Other related sample numbers should be listed in the Collection Remarks field.

4.4.10.3.47 - Resp. Firm Type

Choose the appropriate type from the list of values for the firm most likely to be responsible for a violation. For a 301(k) [21 U.S.C. 331(k)] sample the responsible firm should be "Dealer". You should only enter one firm with the firm type you designate as the responsible firm type.

4.4.10.3.48 - Sample Basis

Select from the four choices on the list of values. "Compliance" means the sample was collected on a selective basis as the result of an inspection, complaint or other evidence of a problem with the product. "Surveillance" means the sample was collected on an objective basis where there is no inspectional or other evidence of a problem with the product. Use the Environmental Compliance “Environ-Compl” or Environmental Surveillance “Environ-Survl” only for environmental samples (see IOM 4.3.7.7). Please note official samples can be either compliance or surveillance, and INV samples can also be either. See IOM Exhibit 4-16.

4.4.10.3.49 - Sample Class

Make a selection from the following list of values: "Collaborative Study"; "Criminal Investigation"; "District Use Sample"; "Normal Everyday Sample"; "Petition Validation"; "Quality Assurance"; "State Partnership"; "Total Diet".

4.4.10.3.50 - Sample Cost

Enter the cost of the sample. If no charge, enter 0. If, as a last resort, you use your personal credit card to pay for the sample, enter the amount paid in this field and select "Credit. Card" in the Payment Method field. If you are unable to determine the cost of the sample and the firm states they will bill you later, enter the estimated cost in this field and state that it is an estimate in the Collection Remarks field.

4.4.10.3.51 - Sample Delivered Date

Enter the date on which the sample was delivered to the laboratory or for shipment. For DOC samples, you must leave this field blank. If you make an entry, you must enter a laboratory.

4.4.10.3.52 - Sample Delivered To

Enter to whom you delivered the physical sample. If delivered to your own sample custodian under seal, show delivery to servicing laboratory or sample custodian. If delivered to an analyst, report e.g., "In person to Analyst Richard R. Doe." If you shipped the sample, enter the name of the carrier to whom the sampled was delivered. Enter the carrier shipment tracking number. If the sample is shipped by air, enter the air waybill number. If shipment is by parcel post, give the location of the post office, e.g., "P.P., Austin, TX." For a DOC sample, this field may be left blank. If the sample is being sent to a non-FACTS laboratory, enter the laboratory here.

4.4.10.3.53 - Sample Description

Briefly describe what the sample consists of, i.e., three unopened, 200 tablet bottles; 20 lb case of iceberg lettuce; or documentary sample consisting of records, literature and photographs, etc.

4.4.10.3.54 - Sample Flags

Click on the "Sample Flags" button to choose an appropriate flag using the list of values. See IOM 4.4.10.1and exhibit 4-15.

4.4.10.3.55 - Sample Number

Select a pre-assigned sample number, using the list of values button, or the system will enter a sample number when the record is saved.

4.4.10.3.56 - Sample Origin

Choose "Domestic" or "Domestic/Import" from the list of values.

4.4.10.3.57 - Sample Sent To

Choose appropriate lab from the list of values. Select the laboratory to which you are sending the sample. If you are splitting the sample among multiple laboratories for various analyses, enter each laboratory separately. Generally, in that case you will have more than one PAC code. If, because of your assignment, you are aware the sample should be forwarded to a second laboratory after the first analysis is complete, include that information in the Collection Remarks field. However, you should only enter a laboratory in this field if you are sending the sample there, not if the laboratory will be expected to forward it. For a DOC sample, leave this blank. If the sample is to be sent to a non-FACTS lab, leave this field blank, enter the lab in the Sample Delivered To field, print a copy of the collection record and enclose it in the FDA 525 attached to the sample.

4.4.10.3.58 - Sample Type

Make a selection from the list of values. You can enter only one value. If more than one type applies, choose one and indicate the other in remarks. If the sample is a domestic import, be sure to enter "DI", so that you can enter the foreign manufacturer. See IOM 4.4.10.2.4.

4.4.10.3.59 - Sampling District

Make a selection from the list of values. This is the district that actually collects the sample.

4.4.10.3.60 - State

Select the State where the sample was collected. This field is optional for many samples. Always use it for pesticide samples.

4.4.10.3.61 - Status

This field is pre-filled by the system as "In-Progress". Select "Ready for Review", from the list of values, when you are ready to send the record to your supervisor for review, if you are required to do so. After supervisory review, if appropriate, change the status to "Complete". This will cause the electronic signature form to be activated.

4.4.10.3.62 - Storage Requirements

Select from the following list of values: Ambient; Frozen; Refrigerated.

4.4.10.3.63 - 702(b) Portion Collected

Check this box if you collected the duplicate portion of food, drug or cosmetic to be held by FDA for release to the owner or person named on the label for their own analysis. Note: for routine surveillance samples, collected per a sample schedule, the sample size usually includes the 702(b) portion. If you did not separate the 702(b) portion, note this in the remarks so the laboratory can separate the 702(b) portion.

4.4.10.3.64 - 704(d) Sample

Check this box if the sample is collected during an inspection (e.g., a FDA 482 has been issued) of a food manufacturer, processor or packer, and the firm is entitled to a copy of the analytical results. See FMD 147. Include in Collection Remarks name, title, and telephone/fax number of the responsible person at the firm. See also IOM 4.1.1.4.

4.4.10.4 - Servicing Laboratory Table (SLT)

The National Sample Distributor (NSD), implemented in October 2007, is currently inactive with the potential to be phased out completely. All lab capabilities have been set to "0" and the lab servicing tables programmed into the NSD are not correct.

Collecting Districts are instructed to submit samples utilizing the Servicing Laboratory Table (SLT) located in the ORA Workplan. The SLT is a complete, current listing of designated servicing laboratories that identifies the servicing laboratories for each collecting district and for each compliance program or subpart. The SLT is provided to every District in conjunction with the Workplan and contains multiple tabs according to lab specialty.

The NSD will continue to appear to be active in FACTS/when completing a sample collection CR. If the servicing laboratory presented does not match the specific assignment instructions or the SLT, override the NSD.

4.4.10.4.1 – Other Information

The Office of Regulatory Science intranet website maintains current documents related to the Laboratory PAF managers Contact List and the District Compliance Contacts. Questions on sample analyses, assignments, laboratory capability, or otherwise can be directed to the Office of Regulatory Science contacts listed at that site.

Additional information on sample collections/laboratories, including assignments, SCOPE and contacts, can be found at

Field Guidance- http://inside.fda.gov:9003/ProgramsInitiatives/FieldOperations/FieldGuidance/default.htm

Field Programs- http://inside.fda.gov:9003/ProgramsInitiatives/Food/FieldPrograms/default.htm

Also reference 4.5.5.2 - Routing of Samples.

4.4.10.5 - Routing

Anyone who has user access to the FACTS system has access to the electronic records contained therein, including sample collection records. Individuals requiring sample collection data can query the system and retrieve data, based on the query parameters. In those cases where an individual needs to receive immediate notification of a sample collection, the collector may communicate the sample number via E-mail, telephone, or another means to a user, and the user may then query the system and obtain the desired data. It is not always necessary to print paper copies of FACTS sample collection records for those who have access to FACTS.

Routing Records Accompanying Sample Collection Record - Print a copy of the Collection Record in FACTS. Attach original records to the printed FACTS Collection Record and route, through your supervisor, to the district office compliance unit most likely to take regulatory action. When requested, additional copies should be routed, attached to a routing slip, marked "records to accompany CR _________(number), as requested." Include a copy of the printed FACTS Collection Record in the FDA 525 if it is available at the time of sample shipment.

When a sample is to be billed, route a copy of the FDA 484, if issued, annotated with the FACTS sample number to the appropriate fiscal unit for your district. If possible at the time of collection, provide the FACTS sample number to the firm and request that this number be placed on the billing invoice. If no sample number is available, ask the firm to identify the bill with your name as the collector to help the fiscal unit match the bill to the sample record in FACTS. The fiscal unit will have access to the sample collection record in FACTS to obtain detailed sample information.

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