Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 7.3 - MONITORING RECALLS
7.3 - MONITORING RECALLS
7.3.1 - INSPECTIONS TO MONITOR RECALL PROGRESS
7.3.2 - FDA RECALL AUDIT CHECKS
184.108.40.206 - Definition
220.127.116.11 - Level of Audit Checks
18.104.22.168 - Sub-Account Checks
22.214.171.124 - Conducting the Check
126.96.36.199 - Audit Check Reporting
188.8.131.52 - Ineffective Recalls
7.3.3 - RECALL TERMINATED/RECALL COMPLETED
184.108.40.206 - Definitions
220.127.116.11 - Closeout Inspection
It may be necessary to re-inspect the firm between the initiation and closeout of a recall to monitor its progress and verify the recalled product's disposition. These visits are limited inspections; issue an FDA-482, Notice of Inspection, at each one. Request recalling firms submit periodic status reports to FDA. See 21 CFR 7.53.
A recall audit check is a personal visit, telephone call, letter, or a combination thereof, to a consignee of a recalling firm, or a user or consumer in the chain of distribution. It is made to verify all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action.
Level A - 100% of the total number of consignees to be contacted.
Level B - Greater than 10% but less than 100% of the total number of consignees to be contacted.
Level C - 10% of the total number of consignees to be contacted.
Level D - 2% of the total number of consignees to be contacted.
Level E - No effectiveness checks.
NOTE: A statistical audit plan may be directed by the Center involved.
If a recall strategy includes sub-recall by a firm's direct accounts, sub-recall checks will be made following the above levels, as instructed by the Center and your supervisor.
Your assignment contains the necessary details of the recall, recall strategy, and a list of accounts to be checked. The Center will indicate how checks will be made, i.e., visit, phone calls, record checks, etc. Obtain at least the following information, plus any additional information requested by the monitoring district or your home District:
- Name and title of person interviewed;
- Was notification received, understood, and followed?;
- Date and method of notification;
- Amount of recalled product on hand at time of notification;
- Amount returned and the method of return;
- Amount destroyed and method of destruction;
- Amount presently on hand and its status (held for sale, awaiting return, etc.);
- Date of anticipated return or destruction, and planned method (if applicable);
- Was sub-recall conducted? (If so, obtain a list of consignees from which to select your sub-recall check locations); and
- Have injury reports or complaints been received? If so, report details.
When you conduct an audit check by visit, you should visit the storage sites for the recalled product and check the shelf stock to ensure all recalled product has been identified, removed from areas of use and properly quarantined. In firms where products are stored in multiple locations, a sufficient number should be checked to verify the consignee properly found and removed all product subject to the recall. This is especially important in Class I recalls and you should check each storage site.
The narrative results of your audit check should be reported on an FDA 3177, "Recall Audit Check Report" form. See IOM Exhibit 7-2. Districts have the option of using computer generated audit check forms or hard copies. The FDA 3177 is a three-part form, which is basically self-explanatory. If necessary, instructions for completing it may be found in RPM, Chapter 7, Exhibit 7-12. It is distributed as follows:
Original - Monitoring district.
CC - Accomplishing district files.
CC - District Use
Version 2 of FACTS allows you to enter the amount of time and other data information. When you complete Recall Audits, you should report your time using the "Miscellaneous Operations Accomplishment Hours" screen. You do not need to report the information on the 3177 unless your District SOP requires this. Until some other reporting procedure is developed, continue to report audit checks using the FDA 3177 form or memorandum.
If your audit check discloses recalled product being held for sale, or a requested sub-recall has not been initiated, document the responsibility for failure to follow recall instructions. This is particularly important if the account received the recall notice and ignored it. An Official Sample should be collected from these remaining products. If in doubt, contact your supervisor or R&E Coordinator. Encourage the consignee to follow the recalling firm's instructions. If a sub-recall is justified, obtain a commitment and details of the firm's sub-recall effort. Get distribution information for follow-up sub-account audit checks.
Recall Terminated - A recall will be terminated when the FDA determines that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and when it is reasonable to assume that the product subject to the recall has been removed and proper disposition or correction has been made commensurate with the degree of hazard of the recalled product. Written notification that a recall is terminated will be issued by the appropriate District office to the recalling firm.
Recall Completed - For monitoring purposes, the FDA classifies a recall action "Completed" when all outstanding product, which could reasonably be expected is recovered, impounded, or corrected.
The final monitoring step is a limited inspection made to verify recall closeout by the recalling firm. A memorandum or limited EIR should be prepared. See RPM Chapter 7, Attachments B1, “Recommendation for Recall Classification and Termination” and Attachment C, “Recall Termination or Recommendation for Termination” for the format. Portions of this format (i.e., Section II and certain items in Section III) will be completed by your supervisor, R&E Coordinator, or compliance officer, depending upon your District's policy.
During the closeout inspection, you should witness destruction or reconditioning of the recalled product when possible. If you are unable to witness the destruction or reconditioning, obtain written documentation from the firm and/or any state or local government agencies which may have witnessed or otherwise verified product disposition. The disposal of large amounts of contaminated or hazardous items may require the firm to file an Environmental Impact Statement (EIS), or pre-disposal processing to render the goods harmless. Do not agree to witness destruction without resolution of these issues. Obtain a "Letter of Voluntary Destruction" from the firm whenever you witness this operation. See IOM 18.104.22.168.