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Report (OEI-02-09-00430)

12-13-2011
Vulnerabilities in FDA's Oversight of State Food Facility Inspections

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Summary

Although FDA has increasingly relied on States to inspect food facilities, our report identified significant weaknesses in FDA's oversight of these inspections. Notably, in eight States, FDA failed to ensure that the required number of inspections was completed. Moreover, FDA paid for many inspections that were incomplete.

In addition, FDA did not ensure that all inspections were properly classified or that all inspection violations were remedied. Based on the violations found during an inspection, FDA assigns each inspection a classification; an official action indicated (OAI) classification is generally assigned when the most serious violations are identified. We found that FDA officials were often unclear about how to properly classify contract inspections. Specifically, officials responsible for 11 States reported that they would not assign OAI classifications to State inspections under any circumstances, contrary to FDA guidance. Additionally, FDA officials reported that when States are responsible for correcting violations, FDA was not always informed about actions taken by the States. As a result, FDA was unable to ensure that all inspection violations were remedied.

Finally, FDA failed to complete the required number of audits in one-third of the States with inspection contracts. FDA guidance requires that a minimum of 7 percent of a State's contract inspections be audited each year. However, FDA failed to complete the required number of audits in 14 of 41 States. Additionally, the audits in 10 States revealed systemic problems that needed to be corrected; however, FDA initiated corrective action in only 4 of these 10 States.

We recommend that FDA: (1) ensure that all contract inspections are completed, properly documented, and appropriately paid for; (2) ensure that contract inspections are properly classified in accordance with FDA guidance; (3) ensure that all inspection violations are remedied by routinely tracking all actions taken to correct violations; (4) ensure that the minimum audit rate is met in all States; and (5) address any systemic problems identified by audits. FDA concurred with four of our recommendations and agreed in part with the fifth.

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