Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 6.5 - IMPORT SAMPLE COLLECTION

Table of contents

6.5.1 - GENERAL

In general, the difference between Official Domestic and Import Samples is that import samples do not require official seals or collection of a 702(b) reserve portion. However, these are district options. See Chapter 4 for sampling instructions and guidelines. There will be instances when the collection of a reserve portion and an official seal is warranted, i.e., when enforcement action (e.g., seizure, injunction, prosecution) is contemplated. Many sample sizes are provided in the Sample Schedule Section (Chapter 4). When using the sample sizes furnished elsewhere in this manual, do not collect the duplicate portion of the sample unless directed by your district. In addition, when preparing to collect import samples, you should be aware of your personal safety. Refer to IOM 5.2.1.2.

FDA does not pay for import samples at the time of collection. The Importer should be told to bill the responsible district. FDA will not pay for violative import samples, per 21 CFR Part 1.91, see IOM 6.2.4.5.

When collecting IMPORT "ADDITIONAL Samples", the original Import Collection Report (CR) number should be used. Under OASIS, this will be the entry number with appropriate line information, etc.

Import Samples are compliance samples, except for those collected for pesticide analysis. These samples MUST BE FLAGGED either "Pesticide Surveillance" or "Pesticide Compliance" depending on the basis for sampling. See IOM Sample Schedule Chart 3 (Chapter 4) for guidance.

6.5.2 - PROCEDURES

Review the submitted entry (electronic or hard copy documentation) to assure the location of the product(s) is known and the lots are available for FDA examination/ sampling before initiating action. The general description of the shipment in the entry documentation submitted to FDA should match the description of the product(s) in the invoice from the broker.

6.5.3 - TECHNIQUES

Follow guidance furnished in IOM Subchapter 4.3 - Collection Technique.

6.5.4 - IMPORT FORMS PROCEDURES

Because forms are now generated electronically by OASIS, individuals performing field examination or sample collections should follow guidance provided in the OASIS Training Manual, or consult their lead OASIS personnel.

6.5.5 - SAMPLE COLLECTION REPORTS

See IOM 1.1 English language requirement. For every sample collected, a corresponding electronic collection report must be completed in OASIS. (See IOM Exhibit 6-4.) Highlighted to denote updated text

Prior to completing the collection report, review the Line Details for the product sampled. You are responsible for making sure all fields in the Line Details screen are complete and correct. The Line Details screen is the only place you can make corrections to the entered data. Highlighted to denote updated text

NOTE: If you start a collection report and need to exit at any time to make a correction in the Line Details you will lose the original collection report and a new lab number will be assigned when you return to the Collection Report screen. Highlighted to denote updated text

To review the Line Details: Highlighted to denote updated text

  1. Access the Line Details screen by double clicking the work type field, i.e. “SAM”. This will open the Entry/Line Summary screen. Click the “Line Details” button. Highlighted to denote updated text
  2. Review all data and verify that it is complete and correct. For example, make sure the product code matches actual product, and that the manufacturer, country of origin, quantity and value are correct. Add any lot codes if applicable and update the Line Availability information if needed. If there is a build button on the line you need to correct, you must use the build function to make corrections. All fields that are white or highlighted in purple can be updated. Highlighted to denote updated text
  3. If data has been changed, click the “Save” button, then enter a brief description in the pop-up box of corrections made. Assign fault to any errors as appropriate. Highlighted to denote updated text
  4. After any changes are saved, click on “Rescreen” in the Application Tool bar to see if changing the data caused the line to hit on any other criteria or alerts. Highlighted to denote updated text

Complete the OASIS Collection Report: Highlighted to denote updated text

  1. Highlight the line sampled in your Personal In Box and click on “Wk Detail” in the Application Toolbar. Highlighted to denote updated text
  2. If the line was sampled for more than one PAF, and analysis will be performed at the same laboratory, only one collection report should be generated; unless otherwise directed. Use Ctrl+Click to highlight all PAFs going to the same laboratory. Highlighted to denote updated text
  3. If the sample will be split and sent to more than one laboratory, highlight the PAF(s) for each laboratory individually and complete a separate collection report for each laboratory. Highlighted to denote updated text
  4. Click the “Work Result” button near the top right of the screen to access the Product Collection screen. Highlighted to denote updated text

OASIS completes the following fields for you: Entry number, Investigator initials, Date Collected, Product Code, Product Code Description, Importers Corrected Description, Location of Goods, and the Lab Number. The Date Collected, and Location of Goods can be corrected on this screen if needed. Highlighted to denote updated text

Enter data in the following fields: Highlighted to denote updated text

6.5.5.1 - Collection Date

The Date Collected should reflect the date the sample was collected, not the date the sample was entered into OASIS. Only one date can be entered. If the sample collection was accomplished over several days use the last date of collection. Be consistent. This date should also be used to identify the physical sample. Highlighted to denote updated text

6.5.5.2 - 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). For example, 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. Enter the episode number. See IOM 4.4.10.1.8. Highlighted to denote updated text

6.5.5.3 - Submitted To

To select the appropriate servicing laboratory click the “Get Lab” button. The National Sample Distributor (NSD) is currently inactive. All lab capabilities have been set to “0”. Districts are instructed to submit samples utilizing the Servicing Laboratory Table (SLT) located in the ORA Workplan. If the servicing laboratory presented by the NSD does not match the specific assignment instructions or the SLT, override the NSD. (See IOM 4.4.10.4.) The NSD-assigned laboratory can be overridden by choosing another laboratory from the drop down menu. Override Reason must also be selected from the dropdown menu. Click “Proceed” to return to the collection report. The chosen laboratory should be displayed in the Submitted To field. Highlighted to denote updated text

6.5.5.4 - Quantity Collected

Enter the number of sampled units you collected.

6.5.5.5 - Units

Select the appropriate units from the pull-down menu. The Calculated Cost will automatically populate based on the Value submitted in the Line Details, Quantity Collected and Units selected. Highlighted to denote updated text

6.5.5.6 - DescText

Enter a description of the sample. The description should include: Highlighted to denote updated text

  1. Number of subs collected Highlighted to denote updated text
  2. Weight/volume of each sub Highlighted to denote updated text
  3. Brief product description Highlighted to denote updated text
  4. Type of container the subs were collected in Highlighted to denote updated text
  5. Lot sampled Highlighted to denote updated text

Describe how you collected the sample: Highlighted to denote updated text

Specify any special sampling techniques; if the sample was collected randomly, aseptically, selectively, etc. and the number of master cases collected from. Highlighted to denote updated text

For example: "Sample consists of 12 subs /16 oz (1lb) each of IQF Cod Fillets collected at random from lot B129A1. Sample was collected aseptically from 12 master cases and packed in 12 whirl-pak bags."

Any text you enter in this field will be printed on the "Notice of FDA Action”. This field transfers to the “Sample Description” field in FACTS. Highlighted to denote updated text

6.5.5.7 - Hand Ship

Enter the method of shipping and describe how sample integrity is maintained including sample chain of custody. Highlighted to denote updated text

  1. Describe how the sample was held and stored until shipment. Highlighted to denote updated text
  2. Include how the sample was prepared for shipping and Highlighted to denote updated text
  3. Method of shipment Highlighted to denote updated text

For example: "Transported from firm in a closed cooler with gel packs, sample was then transferred to freezer #1 in the locked sample room until shipped via UPS to PRL- NW in a cooler with Gel packs." Highlighted to denote updated text

NOTE: This field does not transfer to FACTS for the laboratory to view. Please enter any special handling instructions in the Remarks field. Highlighted to denote updated text

6.5.5.8 - Remarks

Enter any additional information that is pertinent to the sample collection such as: Highlighted to denote updated text

  1. Special handling instructions or storage condition requirements as necessary; Highlighted to denote updated text
  2. Additional information your District, Laboratory, Compliance Program, Assignment, or Import Alert/Bulletin requires; Highlighted to denote updated text
  3. Any specific analysis instructions needed (i.e. any specific pathogen or mycotoxin screen needed.) Highlighted to denote updated text
  4. Any controls collected Highlighted to denote updated text

For example: “Store frozen. Master case code: PRODUCTION DATE 1319. Open and closed controls submitted with the sample. Analyze for milk protein per IB XX-BXX” Highlighted to denote updated text

This field transfers to the “Collection Remarks” field in FACTS. Highlighted to denote updated text

NOTE: Be sure to review the entire screen before clicking “OK.” The sample will be transferred immediately in FACTS to the respective laboratory once the OK button is clicked, (unless your supervisor has set up a supervisory review of your work). Highlighted to denote updated text

6.5.5.9 - Record Time Screen

The Record Time Screen will appear. Enter your time. If more than one person worked on the sample, click on "add" button to the right. A box will pop-upHighlighted to denote updated text; enter the person's initials and the tab key. Highlight the person's name, click on OK. Enter other person's time. Repeat for each person that worked on the sample. Click on OK Note: time is entered in decimal format for OASIS.

6.5.6.0 - Updating a Sample Collection Report Highlighted to denote updated text

OASIS will allow users to make corrections to collection reports until the laboratory has set the sample to “In Progress” in FACTS. Note that a collection report may only be corrected once. To update a collection report, query the entry by clicking on “Query”and then “Entry”. From the Entry Query screen enter the entry number and click on “Execute Query”. Once you are at the Entry Details screen, select the line you want to update and click “All Activities”. Finally, double click on the “Product Collect Comp” field under the Pending text column to open the collection report and click the “Update” button. The updatable fields will become enabled for modification. They are Quantity Collected, Units, Desc Text, Hand/Ship and Remarks. Once all necessary changes have been made, click “Save”. At that point, the “View Update” button will become enabled. If a change was made to the Quantity Collected, Units, or Desc Text the “Print Notices” button will also be enabled. It is very important to generate and send the Notice that notifies the parties that changes were made to the collection data. Highlighted to denote updated text

NOTE: If a change was made to Hand/Ship or Remarks fields ONLY, then no new Notice is needed and the “Print Notices” button will not be enabled. Highlighted to denote updated text

 

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Page Last Updated: 05/06/2015
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