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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Field Management of Recall Operations

Subject:
Field Management of Recall Operations
Area:
Operations Management
Date Revised:
May, 17 1995

 

 

PURPOSE

To provide guidance to field units in the management of recall operations.

 

BACKGROUND

In May 1988, the Regulatory Procedures Manual (RPM), Part 5, Recalls and Emergency, was substantially revised. The revision requires more involvement by both field and center managers in the review and management of recall operations. This Field Management Directive (FMD) was developed to create a more uniform recall management approach across the field and is not designed to be an all comprehensive document but is to supplement operational/management instructions in the RPM.

 

ORGANIZATION AND STAFFING

1. Each district should have a permanently assigned and, if appropriate, full time Recall coordinator. Where the recall workload is insufficient to justify a full time position, investigational and/or other coordinating functions should be added. When the position description can be supported by the regional personnel office, it should be established at the GS-12 level.

The Recall coordinator does not require location within a particular branch, i.e., Investigations Branch vs. Compliance Branch; however, it is important that the Recall coordinator be a responsible individual with sufficient experience and support to function as the district expert in recall matters and to provide guidance to district personnel, as well as industry, in conduction, monitoring, and/or auditing recall operations.

2. The recall position should have one or more designated backups who have been specially trained for the position. Districts should have a formalized training program to prepare backups for the position. On-the-job training accomplished by working side-by-side with the Recall coordinator is the recommended training procedure.

3. Each district will establish and maintain a written S.O.P. on the handling of recalls within the district. This serves as a guide to the Recall coordinator, the backup, district managers, and investigators.

4. Recalls affect all branches within the district, headquarters, and usually other districts' personnel. It is the Agency's responsibility to assure that the recalling firm successfully completes the recall. We have therefore placed "high priority" on the handling and management of the recall activity at the district level. In order to both expedite processing of recalls, and assure the participation and approval of district management, the Recall coordinator in Investigations Branch should report directly to either the Branch Director or the Deputy Branch Director while the coordinator located in Compliance Branch should report to the Branch Director. Normal supervisory review and control must be exercised over non-recall functions of the coordinator.

 

RECALL REVIEW PROCESS

Top district management must be involved in the early stages of the recall process since it is at this time that the firm and the district are developing recall and auditing strategy. The method and content of the firm's notifications and their effectiveness check strategy are critical to the success of the recall. Therefore:

1. Districts should consider Branch Director review of all recall data and of the Recall Recommendation (RR) itself prior to submission to the appropriate center. Recalls which appear to involve serious health hazards and/or will require extensive Agency resources should have the concurrence of the District Director. The District Director will also be the recommending official for "FDA Requested" recalls. The Regional Food and Drug Director (RFDD) must be kept apprised of these significant recall operations.

2. Firm developed recalls letters, press statement, or other communications (especially for potential class I's) should have concurrence of the District and headquarters (for press statements and class I's) prior to approval being provided to the recalling firm.

3. The district's notification letter to the recalling firm normally requests the submission of status reports to a designated representative. In situations where either the firm's status reports or FDA's audit checks find a recall ineffective, the situation should be brought to the attention of the Branch Director for review and necessary follow-up action to be taken. Any contemplated action in this regard should have concurrence of the District Director.

4. In order to assure adherence to established recall timeframes and timely close-out of recalls, the Branch Director or Deputy Branch Director, and District Director should review the bimonthly recall status reports prepared by the Recall coordinator for submission to the respective Center and the Division of Emergency and Epidemiological Operations (DEEO).

5. When a recall has been terminated and Center concurrence received (class I recalls), the termination letter to the recalling firm should bear the District Director's signature.

 

INSPECTIONS/SAMPLE COLLECTIONS

1. Districts should emphasize the importance of, and necessity for, conducting in-depth inspections to determine the cause of a recall and to document violations for possible regulatory actions. The IOM, chapter 8-Recall Activities, provides guidance to investigators.

2. The collection of samples for regulatory consideration is at the district's discretion. An in-depth review of samples collected and reason for the recall for regulatory consideration should be standard operation procedure.

 

LEGAL ACTIONS

As soon as possible after completion of the inspection and submission of the recall recommendation data to the district Recall coordinator, the EIR and all supporting documents should be submitted to Compliance Branch for review. If inspectional findings disclose serious violations, a recommendation for appropriate regulatory action should be considered and processed within the established timeframes.

The districts should not wait until a recall is closed before reviewing recall documents for possible regulatory action.