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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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7-4 - RECALL ENTERPRISE SYSTEM

The Recall Enterprise System (RES) is an electronic data system used by FDA recall personnel to submit, update, classify, and terminate recalls. Districts will not capture and track Market Withdrawals or Safety Alerts in the RES system. The classification types of “Market Withdrawal” and “Safety Alert” in RES were designed to allow centers to use these selections for field recommendations placed in RES that were believed to be recalls by districts. Actions by firms determined to be Market Withdrawals or Safety Alerts by the districts prior to RES entry should not be entered into RES.

Basic recall guidance and procedures remain essentially unchanged from those used prior to the initiation of RES. RES User Guides contain the detailed information needed for the use of RES. Electronic copies of the guides have been provided to field and center recall coordinators. The RES application currently has some help information available for each screen. Additional detailed guidance will be developed and added to the application.

The RES increases efficiency in processing recall information by:

  1. allowing field coordinators to input recall information via an on-line, Intranet system;
  2. combining five separate documents for a recall event into a single system, allowing users to build a record of the entire recall by entering information as it becomes available thus reducing preparation time and providing consistency throughout the agency;
  3. reducing duplication of efforts between the Field Offices, OEIO, the centers, and Office of Public Affairs;
  4. increasing communication of recall information between the field, headquarters, and the appropriate center(s) offices;
  5. providing a central, searchable database to more efficiently track information and generate and disseminate reports of recall activities, and
  6. using a uniform Health Hazard Evaluation (HHE) form or a form equivalent to the HHE form to promote consistency in evaluating potential health hazards and/or risks agency- wide while supporting wider use of electronic precedent health hazard assessment files to expedite recall classifications.

The information entered in RES is gathered from various sources, including the field, the firm, ORA and the CRU. ORA is the business owner for the RES database.

OEIO/DE maintains other documents relevant to these actions on their website at: http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm.