Agency IG Chastises FDA for Lax Food-Facility Inspection Oversight
The Office of Inspector General (IG) of the U.S. Department of Health and
Human Services has issued a report that “identified significant weaknesses in
FDA’s [the Food and Drug Administration’s] oversight” of its contracts for state
inspections of food facilities. In recent years, FDA has increasingly shifted to
the states its responsibility for conducting inspections, and has apparently
“failed to ensure [in eight states] that the required number of inspections was
completed,” “did not ensure that all State inspections were properly classified
and that all violations were remedied,” and “failed to complete the required
number of audits for one-third of the States and did not always follow up on
systemic problems identified.”
Based on an analysis of FDA inspection data and interviews with agency officials, the report, titled “Vulnerabilities in FDA’s Oversight of State Food Facility Inspections,” opens by noting that annually “128,000 Americans are hospitalized and 3,000 die after consuming contaminated beverages and foods.” As an example of possibly faulty oversight, the IG cites the 2009 Salmonella-contaminated peanut outbreak, which led to a massive food recall. According to the IG, the peanut processing facility responsible for the outbreak “was inspected multiple times by a State agency working on behalf of FDA.”
The IG has recommended changes to address the problems, including ensuring that (i) “all contract inspections are completed, properly documented, and appropriately paid for,” (ii) “contract inspections are properly classified in accordance with FDA guidance,” (iii) “all inspection violations are remedied by routinely tracking all actions taken to correct violations,” and (iv) “the minimum audit rate is met in all States.” The IG also recommended that FDA “[a]ddress any systemic problems identified by audits.” While FDA apparently concurred in the first four recommendations, it agreed only in part with the last, noting that “it will continue to develop processes and procedures to ensure that systemic problems are identified and that corrective action plans are implemented.”
