Inspections, Compliance, Enforcement, and Criminal Investigations
7-9 - RECALL TERMINATION
FDA will terminate a recall when the monitoring district office determines that the recalling firm has completed all recall activity, including monitoring and final product disposition. The district should advise the recalling firms that FDA will not terminate a recall until the firm has brought the product into compliance or disposed of it in an acceptable manner. The district will notify the recalling firm by letter that FDA considers the recall terminated. See Exhibit 7-9 for a Model Recall Termination Letter.
Termination of a Class I recall and a Safety Alert requires center concurrence. When the monitoring district concludes that such a recall or Safety Alert has been completed, the district recall coordinator will enter the information required for termination in RES on the "Summary and Termination" page. This page includes fields to provide the: complete reason for recall, quantity recovered or number of units corrected, product disposition, root cause of the problem, section of the law violated, preventative action taken by the firm, legal action by FDA, and name and date of district official approving the termination recommendation. When all required fields have been completed, the coordinator clicks on "continue" at the bottom of the page, which brings up the Summary and Termination validation page. After verifying that all data is correct, clicking on the "Save/Send Termination Recommendation" button will send an email to the CRU recommending termination.
Upon receipt of the termination recommendation email, the CRU will access RES, review the termination information and, if in agreement with the recommendation for termination, provide concurrence in RES (at the bottom of the Summary and Termination page) by inserting the name of the concurring center official. The CRU will change the "recall status" field to "terminated" and click on the "Save/Send Termination Concurrence" button which updates the recall action and generates an email to the district and OEIO/DE advising that the recall is terminated.
Center approval is not required for Class II or III recall terminations. Field coordinators will follow the same basic procedure as outlined above for Class I recalls, but will just change the "status" field to indicate "terminated" and click on the "Save/Send ClassII/III Termination" button. The RES then generates an email to the center and OEIO/DE that the recall has been terminated by the district.
As a rule, FDA should terminate the recall within three months after the firm completes the recall. If the district feels that the recalling firm is unable to ensure that violative goods will not reenter channels of distribution, the district should consult with the CRU and/or OEIO/DE for the best course of action.
NOTE: Before any FDA approval or concurrence is provided to plans for the disposition of recalled products, the district must follow established procedures governing the coordination of toxic wastes/product disposal programs with other federal or state agencies.
The information provided in the Summary/Termination portion of the RES recall record is very important as it not only provides finality to the recall process but provides information used by headquarters to determine trends and to identify or evaluate new problem areas in manufacturing, processing, etc.