Are You in Compliance? OIG Finds Significant Problems with FDA’s Food Facility Registry

December 14, 2009 – According to a Department of Health and Human Service’s Office of Inspector General (HHS/OIG) report released on Friday, almost half of 130 domestic food facilities surveyed by OIG failed to provide accurate information for the Food and Drug Administration’s (FDA) Unified Registration and Listing System (“the food facility registry”). Additionally, five percent of the facilities failed to register with FDA, and two percent did not cancel their registration when required under the law.

The food facility registry was established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act”) and requires that certain food facilities – including AHPA member companies engaged in the manufacturing, processing, packing, or holding of dietary supplements and dietary ingredients – provide certain specified information to FDA to help the agency (1) readily locate facilities during an outbreak of foodborne illness; and (2) locate these facilities for inspection. Retailers, restaurants and transporters are among the narrow group of exempt entities.

“Proper registration under the Bioterrorism Act helps FDA find the source of contamination during an outbreak of foodborne illness and remove contaminated products from the supply chain,” said Executive Director Devon Powell. “IASC encourages companies to confirm the accuracy of their registrations, properly inform and train employees in this obligation and provide optional contact information to FDA as appropriate.”

According to OIG, 52 percent of managers (67 of 130) at the surveyed facilities were either unaware of FDA’s registry requirement (5 of 67) or unaware the law required them to update the information in the registry within 60 days of a change in the facility’s information (62 of 67).

The most frequent pieces of information that were either inaccurately or not reported by companies were:

* Contact information for the facility
* Emergency contact phone number
* Contact information for the owner or operator
* Contact information for the parent company

OIG writes, “Facility managers most commonly reported that they failed to provide FDA with accurate information either because they did not update the information for the registry as required; they incorrectly entered the information during the initial registration; or the responsibility for maintaining the registration was transferred to another person who mistakenly reregistered the facility.” OIG also notes several facilities had multiple registrations for the same facility.

The OIG report is available here http://oig.hhs.gov/oei/reports/oei-02-08-00060.pdf

For additional information see the FDA Web site: http://www.fda.gov/Food/FoodDefense/Bioterrorism/FoodFacilityRegistration/default.htm