Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 6.2 - IMPORT PROCEDURES

 

Table of contents

6.2.1 - SCOPE

The procedures in this section cover imported goods. Your personal safety during any import procedures outlined in this subchapter is important. For more information concerning personal safety, see IOM 5.2.1.2.

6.2.2 - DIVISION OF AUTHORITY

FDA determines if an article is in compliance with the Acts it enforces. It also determines whether or not the article can be brought into compliance with the appropriate statute and authorizes reconditioning for that purpose.

Supervision over the reconditioning is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to an FDA office, supervision is ordinarily exercised by FDA. At remote ports supervision may be exercised by Customs.

The refusal of admission, exportation, or destruction of goods is carried out under the direction of Customs. However, at some ports the actual supervision of the destruction of violative goods may be conducted by FDA pursuant to a local FDA/Customs agreement.

6.2.3 - ENTRIES

6.2.3.1 - Formal Entries

All articles offered for entry into the U.S. and subject to the Acts enforced by FDA, with a value greater than $2500Highlighted to denote updated text (current), are considered formal entries. They are subject to bond requirements, which include a condition for the redelivery of the goods, or any part of it, upon demand by Customs at any time, as prescribed for in the Custom's regulations in force on the date of entry. (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)], 19 CFR Part 113) The bond is filed with Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. (See 19 CFR Section 113.62(l) and 21 CFR Section 1.97).

Notification of the Customs entry is generally accomplished by electronic submission through the Customs Automated Commercial System (ACS). Non-electronic entries are submitted directly to FDA. Electronic entries received by FDA may be subject to on screen review (OSR) to determine if further action is needed, or if full documentation must be submitted. For entries requiring further review, FDA will be provided the appropriate Customs Entry documents (CF 3461/3461ALT, commercial invoice, bill of lading and any other relevant documents to aid in making an admissibility decision), which also document interstate commerce. If an entry is not filed electronically, these documents will be submitted to FDA at the time Customs entry is made, in accordance with local port operations.

6.2.3.2 - Informal Entries

Normally, informal entries (value less than $2500 Highlighted to denote updated text currently) do not require posting a redelivery bond. All informal entries of articles subject to FDA jurisdiction, entered electronically, are forwarded to FDA through the Customs/FDA ACS interface. When FDA takes action on an informal entry not filed electronically by the filer, FDA personnel will input the informal entry into OASIS as a manual entry. When taking FDA action with an informal entry, Customs will be requested to convert it into a formal consumption entry.

6.2.3.3 - Mail/Personal Baggage

In the case of imports by mail or personal baggage, FDA districts should arrange for coverage with their local Customs International Mail Office or border crossing office. This should include agreements designating who is responsible for coverage, when (how often), etc. Customs is responsible for examination of personal baggage. If an article subject to FDA review is encountered, the Customs officer will determine if it should be brought to the attention of the local FDA office. Personal importations meeting the criteria of a formal entry will be processed in accordance with normal non-electronic entries. Generally, since most personal importations are small in size and value, guidance has been developed for evaluating these importations. (See RPM Chapter 9-2 "Coverage of Personal Importations".)

"Section 321 entries" for Customs are those entries with a value of $200 or less. Generally, this form of entry applies to articles which pass free of duty and tax, as defined in 19 C.F.R. 101.1(o), and imported by one person. Customs and FDA may conduct periodic "blitzes" to determine the volume and type of FDA-regulated goods admitted under "Section 321 entries." The use of the 321 entry process should not apply to multiple shipments covered by a single order or contract, sent separately for the express purpose of securing free entry and avoiding compliance with pertinent law or regulation.

6.2.3.4 - Import for Export (IFE) Entries

PRODUCTS IMPORTED UNDER THE PROVISIONS OF SECTION 801(d)(3) OF THE FD&C Act [21 U.S.C. 381 (d)(3)]: Import For Export (IFE) Processing and Follow-Up

PURPOSE: To establish procedures facilitating the uniform review of Import for Export (IFE) at the time of entry and domestic follow up to insure articles entered as Import for Export are either exported or destroyed but not distributed domestically.

REFERENCES: Regulatory Procedures Manual Chapter 9-15, Federal Food, Drug, and Cosmetic Act

BACKGROUND: Section 801(d)(3) of the FD&C Act [21 U.S.C. 381 (d)(3)] allows the importation of certain violative FDA-regulated articles into the U.S. on a conditional basis that they are not for domestic distribution. Those articles include human and veterinary drugs (or their components); device components or accessories, or other devices requiring further processing for health-related purposes; and food additives, color additives and dietary supplements including in bulk form. They must be explicitly intended for further processing or incorporation into other products and subsequent export.

Documentation required at the time of importation under section 801(d)(3) of the Act [21 U.S.C. 381 (d)(3)] includes:

  1. A statement that article is intended to be further processed or incorporated into a drug, biologics product, device, food, food additive, color additive or dietary supplement that will be exported under sections 801(e) or 802 of the FD&C Act [21 U.S.C. 381 (e) or 382] or section 351(h) of the Public Health Service Act (PHSA);
  2. Information to identify the manufacturer of the article and each processor, packer, distributor, or other entity in chain of possession from manufacturer to importer;
  3. Such certificates of analysis as necessary to identify the article, unless it is a device or falls under section 801 (d)(4) of the FD&C Act [21 U.S.C. 381 (d)(4)] - blood and blood components;

In addition, an IFE applicable bond must be executed providing for payment of liquidated damages in accordance with CBP requirements.

6.2.3.4.1 - IFE ENTRY REVIEW

Import for Export entry procedures are as follows:

  1. If electronic submission is made, it is unlikely all of the information required under section 801(d)(3) FD&C Act [21 U.S.C. 381 (d)(3)] will be provided electronically. Districts should request the supporting documents (if not already received from the broker or importer) by setting an entry option of Documents Requested (DRQ) and/or Entry Incomplete (DEF) on all entries with IFE in the Affirmation of Compliance (AOC) field in OASIS, or those suspected to be IFE, which lack complete supporting documents.
  2. If the entry is indeed an IFE entry and the AOC was not included in the original entry, the entry reviewer should modify the AOC field in OASIS to indicate “IFE”.

    If the required documentation is not provided after a DRQ, entry reviewers should take the appropriate compliance follow-up, under the basis the required IFE documentation was not provided to FDA at the time of initial importation.

    Districts should determine the appropriate time frame for receiving the required IFE documents in particular circumstances. It is anticipated three (3) days from the DRQ or DEF notice will usually be adequate for the required IFE documentation to be submitted. This is because the broker may need to communicate FDA’s requirement for documents to an importer. If all required documentation is provided, the entry should be given a “May Proceed”. NOTE: All documentation supporting the IFE entry should be processed in accordance with step 4 below.

    If documentation is not adequate, the district should issue a detention after review of the documentation, in accordance with normal procedures outlined in the RPM Chapter 9.

  3. If the entry is marked IFE, but review of the entry information or supporting documents indicates the AOC was entered inappropriately, the entry reviewer should note this in the entry remarks section.
  4. Copy and attach all entry documentation and forward to the FDA home district of the initial owner or consignee, identifying the following: 
    1. FOREIGN MANUFACTURER/SHIPPER
    2. ENTRY NO.
    3. U.S. IMPORTER OF RECORD
    4. INITIAL OWNER/CONSIGNEE
    5. ARTICLE/PRODUCT  

6.2.3.4.2 - DOMESTIC FOLLOW-UP OF IFE ENTRIES

The FDA home district of the initial owner or consignee should:

  1. Ensure the IFE Entry is copied from the list of IFE shipments for the last 30 days which is generated by the Division of Import Operations (DIO).
  2. Ensure supporting documents are sent to the establishment file of the initial owner or consignee.
  3. Ensure follow-up inspections are conducted within 6 - 9 months of the initial notification the firm is receiving an IFE entry. All existing IFE entries for the firm should be investigated during the initial IFE inspection. If the product has not been "further processed" or "incorporated" into product for export, the home district should monitor the firm's practices to ensure there is no violation of the IFE provisions of the Act.  

6.2.3.4.3 - IFE DOMESTIC INSPECTION GUIDANCE

When a firm is scheduled for inspection, you should:

  1. Review the IFE entry documentation and/or follow-up inspection information from the establishment file prior to conducting the inspection.
  2. Verify during the inspection if the IFE article:
    1. Was used to produce an exported product,
    2. Was destroyed, or
    3. Still under the firm’s control pending disposition. If the article is pending disposition, verify that a current and valid Customs bond covering the article exists, and the article is the same article that was offered for entry.

If the article was exported or destroyed, you should request the manufacturer's import, export, and/or destruction records to verify the imported article was further processed or incorporated into another product and was exported in accordance with sections 801(e) or 802 of the FD&C Act [21 U.S.C. 381 (e) or 382] or section 351(h) of the PHSA, or destroyed. Please note, for drug products, an initial owner or consignee may be allowed to retain a sample of the imported article in order to comply with good manufacturing practices (GMP) regulations concerning sample retention.

Include in the Establishment Inspection Report or a memo the status of the IFE product and if further follow-up is required.

Following review and determination of the necessity of further follow-up, forward the completed EIR or memo and supporting documents to the District which initiated the IFE follow-up.

Upon receipt of the completed IFE Follow-up, ensure the following actions are taken:

  1. Verify if further follow-up is needed. If so, schedule a follow-up inspection. If further follow-up is NOT needed, document the completed follow-up.
  2. Any inspections identifying a prohibited act under section 301(w) of the FD&C Act [21 U.S.C. 331 (w)] should be forwarded immediately to the district compliance branch for regulatory action. See RPM Chapter 9. In addition, a copy of the violative inspection findings should be forwarded to DIO immediately.

6.2.3.5 - Prior Notice of Importation of Food and Animal Feed

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires that FDA receive prior notice of food imported into the United States. Most of the prior notice information required by the final rule is data usually provided by importers or brokers to CBP when foods arrive in the United States. The Bioterrorism Act requires that this information also be provided to FDA prior to an imported article of food’s arrival to the United States. FDA uses this data in advance of the arrival of the article of food to review and assess the prior notice data, and determine whether to examine the imported food for potential contamination by bioterrorism act or significant public health risks. Prior notice can be submitted either through ABI/ACS or FDA's Prior Notice System Interface (PNSI).

6.2.3.5.1 - PRIOR NOTICE RECEPTION

Prior notice for food articles subject to the rule must be received and confirmed electronically by FDA no more than 15 calendar days before the anticipated date of arrival for submission made through the PNSI and no more than 30 calendar days before the anticipated date of arrival for submission made through ABI/ACS, and as specified by the mode of transportation below, no fewer than:

  1. 2 hours before arrival by land by road
  2. 4 hours before arrival by air or by land by rail
  3. 8 hours before arrival by water

In addition, prior notice must be received and confirmed electronically by FDA before food is mailed by international mail. (The parcel must be accompanied by confirmation of FDA receipt of prior notice.)

6.2.3.5.2 - PRODUCTS REQUIRING PRIOR NOTICE

Prior notice applies to food for humans and other animals that is imported or offered for import into the United States. For purposes of prior notice requirements, "food" is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act. Section 201(f) defines "food" as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such articles.

Examples of "food" include:

  1. Dietary supplements and dietary ingredients
  2. Infant formula
  3. Beverages (including alcoholic beverages and bottled water)
  4. Fruits and vegetables
  5. Seafood
  6. Dairy products and eggs
  7. Raw agricultural commodities for use as food or components of food
  8. Canned and frozen foods
  9. Bakery goods, snack food, and candy (including chewing gum)
  10. Live food animals
  11. Animal feeds and pet food

6.2.3.5.3 - PRODUCTS EXCLUDED FROM PRIOR NOTICE

Foods that are excluded from the prior notice requirement are:

  1. Food carried by or otherwise accompanying an individual arriving in the United States for that individual's personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution);
  2. Food that is exported without leaving the port of arrival until export;
  3. Meat food products, poultry products and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 USC 601), the Poultry Products Inspection Act (21 USC 451), or the Egg Products Inspection Act (21 USC 1031);
  4. Food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States; and
  5. Articles of food subject to Art. 27 (3) of the Vienna Convention on Diplomatic Relations (1961), i.e. shipped as baggage or cargo constituting the diplomatic bag.  

6.2.3.5.4 - PRIOR NOTICE SUBMISSION

The prior notice must be submitted electronically and contain the following information in accordance with 21 CFR 1.281:

  1. Identification of the submitter, including name, telephone number, email address, and firm name and address
  2. Identification of the transmitter (if different from the submitter), including name, telephone number, email address, and firm name and address. If the business address of the individual transmitting the prior notice is a registered facility, then the facility’s registration number, city, and country may be provided instead of the facility’s full address
  3. Entry type and CBP entry identifier, if available
  4. The identification of the article of food, including complete FDA product code, the common or usual name or market name, the estimated quantity described from the largest container size to the smallest package, and the lot or code numbers or other identifier (if applicable)
  5. If the food is no longer in its natural state (21 CFR 1.276(b)(8)), name of the manufacturer and either (1) The registration number, city and country of the manufacturer or (2) both the full address of the manufacturer and the reason the registration number is not provided
  6. If the food is in its natural state, the name of grower, if known, and growing location
  7. The FDA Country of Production
  8. The identification of the shipper, express consignment operators, carriers, other private delivery service or sender’s if the food is mailed. This is to include the name and full address of the shipper, if the shipper is different from the manufacturer. If the address of the shipper is a registered facility, the submitter may submit the registration number of the shipper’s registered facility city and country instead of the facility's full address
  9. The country from which the article of food is shipped.  If the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed
  10. The anticipated arrival information (location, date, and time). If the food is imported by international mail, the U.S. recipient (name and address). If the article of food is arriving by express consignment operator or carrier, and neither the submitter nor transmitter is the express consignment operator or carrier, and the prior notice is submitted via PNSI, the express consignment operator or carrier tracking number may be submitted in lieu of the anticipated arrival information. For post-refusal submissions, actual date the article arrived is required
  11. The identification and full address of the importer, owner, and ultimate consignee, except for food imported by international mail or transshipped through the United States. If the business address of the importer, owner, or ultimate consignee is a registered facility, then the facility’s registration number also may be provided in addition to the facility’s full address
  12. The identification of the carrier and mode of transportation, except for food imported by international mail
  13. Planned shipment information is applicable by mode of transportation and when it exists. For food arriving by express consignment operator or carrier, when neither the submitter nor transmitter is the express consignment operator or carrier, the tracking number can be submitted in lieu of the Bill of Lading or Airway Bill number and the flight number for prior notices submitted via PNSI
  14. The name of any country to which the article of food has been refused entry.  

6.2.3.5.5 - INADEQUATE PRIOR NOTICE SUBMISSION

Food that is imported or offered for import with inadequate prior notice is subject to refusal and holding at the port or in secure storage facility. FDA provided guidance to its stakeholders and CBP staff on enforcing the prior notice requirements in a Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/FoodDefense/ucm153055.htm. This guidance, however, does not affect FDA's ability to take actions that may be necessary, including conducting inspections for food safety and security concerns or taking any other action under the Federal Food, Drug, and Cosmetic Act. This policy will also not affect the ability of Customs to assess penalties under 19 U.S.C. 1595a disclaimer icon (b) or to take enforcement action under any other authority.

6.2.3.5.6 - PRIOR NOTICE PROCESS

The prior notice process begins with an automated screening process. If additional evaluation of the prior notice information is necessary, all review of prior notice information is performed by the Division of Food Defense Targeting (DFDT); FDA headquarters staff, operating 24 hours a day, 7 days a week. The review process is a manual review by the DFDT. It is designed to identify food products that may pose serious risks to public health so that appropriate action can be taken upon arrival of article of food in the United States. The review process is not impacted by the method of electronic submission. The results of this process are transmitted to CBP.

The DFDT reviews and assesses the prior notice information and may initiate an examination or other action by FDA or CBP of the article of food at the port of arrival or elsewhere, or in the case of rail shipments, within the confines of the closest appropriate examination site. The DFDT will advise the FDA field offices and/or Customs of the inspection requirements. The DFDT is also responsible for communication with submitters regarding the compliance of prior notice, the initiation of refusal or hold due to inadequate prior notices, the response to requests for review of refusals or holds, and the completion of the prior notice process.

In addition to the prior notice process, the OASIS system review will determine if further staff evaluation of the article of food is necessary for admissibility determinations under section 801(a) of the FD&C Act (e.g., subject to the guidance in an import alert). If the food meets the prior notice requirements; the food will be subject to further review by FDA staff for determination of admissibility under section 801(a) of the FD&C Act.

This admissibility examination may take place at the border but may also take place at an examination site, a public warehouse, or other appropriate locations. If FDA determines that refusal under section 801(a) of the FD&C Act is appropriate, the appropriate refusal procedures will be used.

6.2.3.6 - Entry Processing

FDA district offices generally receive notification of all formal and informal entries subject to FDA's jurisdiction at ports of entry located in its territory. However, through the use of Custom's Automated Commercial System and FDA's Operational and Administrative System for Import Support (ACS/OASIS) some electronic entries may be forwarded to off-site districts for processing during certain periods of time, i.e., late night coverage of air carrier hubs.

The most satisfactory and efficient means of getting notification is through FDA's OASIS system. Electronic entries processed through this system are electronically screened against criteria established by FDA for coverage. Automated Broker Interface (ABI) filers using the Customs ACS for cargo release are required to provide FDA information on entries subject to its jurisdiction submitted through ACS. The means of receiving notification for non-ABI/OASIS entries can be arranged through local Customs/FDA District agreements.

6.2.3.6.1 - U. S. CUSTOMS

Customs' ACS uses guides established by each Federal agency to identify which commodities are subject to their jurisdiction. These guides are known as Other Government Agency (OGA) flags. FDA flags are identified as FD0, FD1, FD2, FD3 and FD4.

FD0 indicates the article, even though subject to FDA regulation, may be released without further presentation of entry information to FDA.

For entries flagged FD1 the commodity may or may not be subject to FDA regulation. Electronic entries for the filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to FDA regulation and "Disclaim" the entry. Otherwise, FDA required information must be submitted. FDA review of "Disclaimed" entries is performed periodically to confirm the accuracy of the declaration.

Entries covered by an FD2 flag must include FDA required information.

FD3 indicates that the article may be subject to prior notice under section 801 (m) of the FD&C Act and 21 CFR Part 1, subpart I, e.g. the article has both food and non-food uses. The filer may, based on information received from the importer regarding the intended use of the commodity, specify the entry is not subject to prior notice and "Disclaim" the entry. If the product is an FDA regulated product, but not a food, the entry can be disclaimed from prior notice by using the affirmation of compliance code "PND" in the entry.

FD4 indicates that the article is “food” for which prior notice is required under section 801(m) of the FD&C Act and 21 CFR Part 1, subpart 1. Entries covered by FD4 flag must include prior notice required information.

Electronic entries for Customs review includes all mandatory Customs entry required information, i.e., entry number, entry date, importer identification, port of entry, vessel/voyage information, filer identification, Harmonized Tariff System (HTS) code for product description, information on foreign shipper, country of origin, etc. Through the screening process in ACS, Customs determines if the article is subject to FDA examination (see OGA flag identifications above).

6.2.3.6.2 - FDA

FDA's electronic screening of the Customs ABI/ACS entry requires the filer to provide the following information.

  1. FDA product code. (FDA's product code is not the same as the HTS codes used for Customs screening purposes).
  2. The "Manufacturer's Identification" (MID) code (a Customs designation) of the foreign manufacturer. The MID consists, at a minimum, of the 2 letter identification of the foreign country, the name of the foreign firm, generally made up of the first three letters of the first and second names of the firm, where applicable. Up to 4 numbers, if present in the address, and the first three letters of the city where the firm is located. This code is subsequently transmitted to FDA's screen as the un-coded identified firm.
  3. The MID information of the foreign shipper, including city and country; which may or may not be the same as the foreign manufacturer.
  4. The country of origin; which may be different from the country of origin identified for Customs purposes.

FDA has also established Affirmation of Compliance (A of C) codes which are designed to provide FDA reviewers with information concerning the imported article (example: medical device listing number). Use of the A of C is voluntary, and may or may not provide for a more expeditious screening of the entry.

In OASIS, the FDA forms identified as: "Notice of Sampling," "Release Notice," "Notice of Detention and Hearing," and "Notice of Refusal of Admission," are no longer issued as specific forms. OASIS generates a "Notice of FDA Action" providing information on the actions taken regarding a particular entry line. The notice identifies the specific line(s) of the entry, where appropriate, with the description of the sample collected or intended for sampling, specific line(s) identified as detained, and/or the specific line(s) identified as released, refused, etc. As the status changes for a particular line, a new "Notice of FDA Action" is issued to advise the appropriate individuals of the changes. The use of the designation "Product Collected by FDA," "Detained," "Released," "Refused," etc., or similar wording on the "Notice of FDA Action," meet the requirements of the wording of the law and regulation when applied to "giving notice thereof to the owner or consignee." See Exhibit 6-1.

OASIS notices are designed to be mailed to the addressees. A copy of each notice is produced with the filer, importer of record, and consignee on the addressee line. (If the same firm acts in one or more of those functions, only one copy is produced for the firm.) Notices are official documents which provide FDA decisions on entries. The distribution of the notices is made by FDA, not the filer, to ensure proper notification to the parties involved (i.e., FAX, express pick-up services, postal service, etc.). The intention is for FDA to distribute to the responsible firm without an intermediary.

6.2.4 - SAMPLING

6.2.4.1 - Ports Covered by FDA

For electronic entry submissions, if the filer receives a message indicating FDA review, the filer will provide appropriate entry information to the FDA office having jurisdiction over the port of entry. The filer can also submit the entry documents electronically to FDA via the Import Trade Auxiliary Communications System (ITACS). For those entries submitted by paper, all appropriate entry documents should be included with the package sent to the local FDA office.

After evaluating the entry, if FDA decides to collect a sample, the appropriate individuals/firms will be provided with a Notice for Sampling and advised:

  1. If the entry is to be held intact for FDA examination or sampling;
  2. Only those designated items need be held; etc.  

6.2.4.2 - Ports not Covered by FDA

For those ports where Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port manager to assure FDA notification. If FDA decides to examine or sample articles being entered through such a port, Customs, the importer, and broker will be notified.

Generally, for these entries, examination and/or sampling can take place at the point of destination. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA servicing laboratory. Appropriate information on the entry, sample requirement, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

6.2.4.3 - Entry Sampling

If no examination or sample is requested, FDA will notify Customs and the filer (who is responsible for notifying the importer, or other designated parties). This electronic notification is called a "May Proceed Notice". It indicates the shipment may proceed without further FDA examination. In the ACS/OASIS process, this may occur as a result of the initial FDA/OASIS screening or after the district performs an "On-Screen-Review".

NOTE: Since the article is allowed entry without FDA examination, should the article, at a later time, be found in violation of the law, the Agency is not prevented from taking legal action because the article was allowed admission by FDA without examination at the time of importation. (See section 304(d) of the FD&C Act [21 USC 334(d)]

If an examination or sample is requested, FDA notifies Customs, broker or filer, importer, or other designated parties. Notification is either through the electronic entry system or other form of notification (Notice of FDA Action), to hold the entry and will identify the specific product(s) to be sampled, etc.

6.2.4.4 - Notice of Sampling

When a sample is collected by FDA, a Notice of FDA Action is issued to the importer of record, consignee, and filer. If Customs collects the sample for FDA, the district will enter the entry information into OASIS and issue the Notice of FDA Action.

For those entries where specific lines (items) of an entry are not sampled or examined, the Notice of FDA Action will be amended to indicate which lines (items) "May Proceed." (See RPM Chapter 9-19 "Notice of Sampling" for detailed guidance.)

6.2.4.5 - Payment for Samples

The FDA will pay for all physical samples found in compliance or collected as an audit of private laboratory reports of analysis submitted to FDA in response to detention (See 21 CFR 1.91). (NOTE: This does not apply in the case of an audit sample collected to document reconditioning). See IOM 4.2.8.2 for guidance on sample costs.

Billing for reimbursement should be made to the FDA district office in whose territory the shipment was offered for import. FDA will not pay for a sample if the article is initially found to be in violation, even though it is subsequently released. For this reason, do not pay for samples at the time of collection.

Samples taken in connection with the supervision of a reconditioning are not paid for by FDA.

6.2.5 - PROCEDURE WHEN PRODUCTS CANNOT BE SAMPLED OR EXAMINED

If the entry is still under control of the district inspection operations, and the sample collection cannot be completed, the district may annotate the notice to the filer and importer no product was collected, and return the entry to the flier designating the entry "May Proceed." If the designated product was part of a multi-line entry where other products were collected, the notice issued for the other items sampled will be appropriately updated with the release of the product not sampled.

In the OASIS system, when a notice is issued for the collection or examination of a product, and neither operation is accomplished, the filer will be advised through a revised Notice indicating the article is given a "May Proceed" status. The system will print a status of "May Proceed" in the Line Summary and also print a detail section "Lines Which May Proceed."

In OASIS, the following are definitions used to describe "May Proceed" or "Release" actions:

May Proceed: "Product may proceed without FDA examination. FDA has made no determination the product complies with all provisions of the Food, Drug, and Cosmetic Act, or other related acts. This message does not preclude action should the products later be found violative." (No compliance decision has been made.)

Release: "The product is released after FDA examination. This message does not constitute assurance the product complies with all provisions of the Food, Drug and Cosmetic Act, or other related Acts, and does not preclude action should the product later be found violative." (A compliance decision has been made.)

Districts will follow the appropriate guidance under each of the above procedures, according to their import operations.

6.2.6 - PROCEDURE WHEN NO VIOLATION IS FOUND

If the shipment is found in compliance after examination, the importer of record, consignee (where applicable), filer, and Customs are notified with a Notice of Release. The shipment may be admitted. (See RPM Chapter 9-5"Release Notices" for detailed guidance).

6.2.7 - PROCEDURE WHEN VIOLATION IS FOUND

6.2.7.1 - "Notice of Detention & Hearing"

If examination of the sample or other evidence indicates the article appears to be in violation, and detention is the course of action chosen by the district, the filer, owner and consignee, where applicable, are advised of such action by "Notice of Detention and Hearing." The Notice will specify the nature of the violation charged and designate a site for the owner or consignee (or authorized representative) to appear at a hearing. These hearings are informal meetings with the district, designed to provide the respondents an opportunity to present evidence supporting admissibility of the article. Ordinarily the respondents are allowed 10 working days to appear. However, if for some compelling reason the district determines ten (10) working days are insufficient; this time period may be extended. On the OASIS generated "Notice of FDA Action", this date is identified under the caption "Respond By". A copy of this Notice is also sent to Customs. (See RPM Chapter 9-7 "Notice of Detention and Hearing".)

6.2.7.2 - Response to "Notice of Detention & Hearing"

Response to the Notice of Detention and Hearing may be made personally, by representative or by mail. The importer may present evidence supporting the admissibility of the article, request refusal of admission, propose an effective manner of reconditioning, or a method to remove the product from the authority of the FD&C Act.

6.2.7.3 - Request for Authorization to Relabel or Perform Other Acts

FDA may authorize relabeling or other remedial action upon the timely submission of an "Application for Authorization to Relabel or To Perform Other Action," (Form FDA 766 - See Exhibit 6-2). This form is also available in fillable formats online at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM072766.pdf.

Application may also be made by letter and the execution of a good and sufficient bond by the owner or consignee (See section 801(b) of the FD&C Act [21 U.S.C. 381(b)]). The redelivery bond on file with the District Director of Customs for the particular importation applies to any relabeling or other action authorized, a new bond will not have to be filed.

After review of the application, FDA will notify the importer of its approval or disapproval. If approved the original application will be returned outlining the conditions to be fulfilled and the time limit within which to fulfill them will be noted. Notification to other parties will be made where appropriate. A copy will be retained in the district files. (See RPM Chapter 9-8 "Response (Hearing) to Notice of Detention and Hearing", and RPM Chapter 9-10 "Reconditioning" for detailed guidance).

6.2.7.4 - Inspection after Completion of Authorization to Bring Article into Compliance

After the relabeling or reconditioning operation has been completed, the applicant will submit the "Importer's Certificate" (the reverse side of Form FDA 766, Exhibit 6-2) or advise the district that reconditioning is complete. At this point, FDA may conduct a follow-up inspection and/or sampling to determine compliance with the terms of the authorization, or it may accept the statement from the importer with no further follow-up. The follow-up inspection and/or sampling may be made by FDA or Customs, depending on agreements between the district and the local Customs. The "Report of Inspector" (reverse side of Form FDA 766, Exhibit 6-2), or other appropriately completed summary of reconditioning, should be forwarded to the appropriate FDA office.

6.2.7.5 - Procedure when Conditions of Authorization Have Been Fulfilled

If the conditions of the authorization have been fulfilled, the district will notify the owner or consignee by Notice of Release. This notice is usually identified as "Originally Detained and Now Released." A copy is also sent to Customs and filer. Where there is a non-admissible portion (rejects), they must be destroyed or re-exported under FDA or Customs supervision. A Notice of Refusal of Admission should be issued for the rejected portion. FDA may include in its approval of the reconditioning a provision for the non-admissible portions (rejects) of the reconditioning to be destroyed and not exported.

6.2.7.6 - Procedure when Conditions of Reconditioning Have Not Been Fulfilled

If the initial attempt at reconditioning is unsuccessful, a second attempt should not be considered unless a revised method of restoration shows reasonable assurance of success.

If the conditions of the authorization have not been fulfilled, a "Notice of Refusal of Admission" is issued to the importer, consignee, where applicable, to the filer, and to Customs.

6.2.7.7 - Procedure after Hearing - "Notice of Release"

If, after presentation of testimony, the district determines the article should be released, the importer of record and consignee are issued a "Notice of Release". The Notice will declare the detained goods may be admitted. The Notice will also be identified "Originally Detained and Now Released" and, where appropriate, explain the reason for the change of action. A copy of the Notice is sent to Customs, and all parties receiving the Notice of Sampling/Notice of Detention. (See RPM Chapter 9-5 "Release Notices" for detailed guidance.)

6.2.7.8 - Procedure after Hearing - "Refusal of Admission"

When the importer requests the district issue a “Notice of Refusal of Admission", or the district decides the shipment still appears to be in violation, the importer, owner, and consignee where applicable, are issued a "Notice of Refusal of Admission". On this Notice, the charge(s) is stated exactly as shown on the original (or amended) “Notice of Detention and Hearing”. A copy of the Notice is also sent to Customs. (See RPM Chapter 9-9 "Notice of Refusal of Admission" for detailed guidance.)

The “Notice of Refusal” provides for the exportation or destruction of the shipment, under Customs supervision, within 90 days of the date of the notice, or within such additional time as specified by Customs Regulation. Under OASIS, the Notice will also contain language which includes reference to the requirement for redelivery, and contain all the above required information concerning the product and charge(s). The FDA file remains open until the district receives notification indicating the goods were either destroyed or exported.

FDA is responsible for the protection of the U.S. public regarding foods, drugs, cosmetics, tobacco products, etc. until the violative article is either destroyed or exported.

6.2.7.9 - Payment of Costs of Supervision of Relabeling and/or Other Action

After completion of the authorized relabeling or other action, FDA will submit a detailed statement of expenses incurred, including travel, per diem or subsistence, and supervisory charges, on a Form FDA 790 (See Exhibit 6-3, Charges for Supervision). This is completed by FDA employees regarding the supervision of the authorized relabeling or other action to Customs National Finance Center. The expenses shall be computed on the following basis:

  1. Investigator's time
  2. Analyst's time
  3. Per diem allowance
  4. Travel other than by auto - actual cost of such travel
  5. Travel by auto (mileage, toll fees, etc.)
  6. Administrative support

Future enhancements to FDA import system may result in electronic processing of the supervisory charges submitted to Customs, in which case the Form FDA 790 will no longer be used. (See RPM Chapter 9-11 "Supervisory Charges" for detailed guidance.)

Customs, upon receipt of the charges for supervision, will send a notice for payment to the identified importer of record. The expenses shall include charges for supervision of destruction of the article or rejects. The remittance by the owner or consignee shall be to Customs. Payment of supervisory charges should not be accepted by FDA district offices.

6.2.7.10 - Exportation of Goods Refused Admission

Exportation of refused goods is done under Customs supervision. However, if after a reasonable time, FDA has not received notification of exportation or destruction, the district should investigate the status of disposition. Districts should also consider, under certain conditions, verifying the refused goods have been held intact pending exportation or destruction, or that re-export actually occurred. Guidance on refusals to be verified may change, based on the reason for detention. Each District involved in performing Import Operations has been assigned a set number of import exams of refused entries as part of ORA's Performance Goals.

6.2.7.11 - Bond Action

Under the provisions of the FD&C Act (section 801(b) of the FD&C Act [21 U.S.C. 381(b)]) and Customs regulations (19 CFR 113.62) a bond is required for all conditionally released articles offered for importation. This bond provides relief to the government on the default of the conditions of the bond and the payment of liquidated damages in the amount specified in Customs notice of assessment of liquidated damages for failure to redeliver such goods.

Bond actions are taken when an entry is distributed prior to FDA release and cannot be redelivered, or when an article has been detained and refused and the article is not destroyed or exported in accordance with the requirements of the law.

If district has evidence the entry, or any portion of an entry subject to FDA jurisdiction, was disposed of in violation of the terms of the appropriate Act, or its regulations, or of the terms of the bond, (see 19 CFR Section 113.62(l)(1)) they should immediately contact the appropriate Customs office.

The district, upon receiving evidence the refused article was not exported or destroyed should immediately investigate the matter. See Section 6.1.3 of the IOM, Investigations Involving the Import Process. Send a detailed statement showing the importer's liability under the redelivery bond or other applicable customs bond to the responsible Customs office. If the facts warrant, and the article was under detention, and the Notice of Refusal of Admission has not been issued, immediately issue a Notice of Refusal to the owner or consignee, with a copy to Customs.

Upon the receipt of an application for relief (appeal for Mitigation or Cancellation of Assessed Liquidated Damages), Customs may agree to mitigate the amount of damages. However, in cases involving FDA goods, Customs does not usually mitigate unless FDA is in full agreement with the action [see 21 CFR section 1.97(b)]. (See RPM Chapter 9-12 "Bond Actions" for detailed guidance.)

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