Auditor faults FDA oversight of food inspections by states

Dec 16, 2011 (CIDRAP News) – A federal auditor has found that the US Food and Drug Administration's (FDA's) management of food inspections by state officials on the FDA's behalf has a number of weaknesses, including a failure in several states to ensure that inspections are completed and problems corrected.

The report, released this week by the Department of Health and Human Services Office of the Inspector General (OIG), says that the FDA has not consistently made sure that findings of food safety violations were properly classified and that the agency didn't complete the required number of audits of state inspection programs.

The report makes several recommendations for correcting the problems. It says the FDA concurred with most of them.

The FDA has relied increasingly heavily on state agencies to inspect food facilities, even as the total number of facilities inspected by the FDA or its proxies has dropped, the OIG report says. "In fiscal year (FY) 2009, 59 percent of FDA's food inspections were conducted by state inspectors, compared to only 42 percent in FY 2004," it states. The agency had food inspection contracts with 41 states and spent more than $8 million on the inspections in FY 2009.

As an example of the potential problems, it notes that the peanut processing plant that caused a major Salmonella outbreak in 2009 "was inspected multiple times by a state agency working on behalf of FDA." The outbreak prompted serious questions about the effectiveness of the state inspections. The OIG report was requested by the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related agencies.

The OIG found that in eight states—Nevada, California, West Virginia, Oklahoma, Connecticut, Texas, Maine, and Virginia—the FDA failed to ensure that the required number of inspections was completed. These states were responsible for 2,170 inspections, but 10% of those were not completed during the contract year. Further, the FDA paid for 130 of the 221 inspections that went unfinished, the report says.

Nevada led the list of states with 94 inspections left incomplete, followed by California with 87 and West Virginia with 23, the report shows.

The auditors also determined that FDA officials responsible for 11 states were unclear about how to classify problems found by inspectors. Inspections that uncover the most serious violations are classified as "official action indicated" (OAI), the report notes. In the 11 states, FDA officials said they would not assign OAI classifications under any circumstances, contrary to FDA guidance, the report says. The states were not named.

In addition, FDA officials responsible for 11 other states, which also went nameless, said that when states were responsible for correcting violations, the states did not always report the actions they took, according to the OIG. "As a result, FDA was unable to ensure that serious violations had been adequately addressed."

The FDA's rules require that at least 7% of a state's contract inspections be audited each year to make sure states are meeting contract requirements, the report explains. But in 14 of the 41 states with contracts, the FDA didn't meet the 7% requirement, leaving 38% (85 of 222) of the required audits incomplete. FDA officials generally attributed the failure to lack of resources, such as inadequate travel funds or too few inspectors.

In addition, the audits in 10 states showed systemic problems, but the FDA took corrective action in only 4 of those 10.

The OIG made five recommendations to correct the problems, calling on the FDA to ensure that all contract inspections are completed and documented, inspection results are properly classified, violations are remedied, the minimum audit rate is met in all states, and systemic problems revealed by the audits are addressed.

The report says the FDA concurred with four of the recommendations and agreed with the fifth in part. In response to the recommendation that the FDA track all actions taken to correct violations, the agency said that "certain violations may not be suitable for inspection follow-up and that other approaches may be used to track such violations," the document states.

The FDA also said it is conducting a systematic review of the state contracting program.

See also:

Dec 13 OIG report summary

Full OIG report

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