By Ricardo Carvajal -
Earlier this month, the HHS Office of Inspector General ("OIG") issued a report that identifies a number of “significant weaknesses” in FDA’s oversight of food facility inspections conducted by state agencies under contract with FDA. OIG found that FDA:
- “failed to ensure that the required number of inspections was completed"
- “paid for many inspections that were incomplete”
- “did not ensure that all State inspections were properly classified and that all violations were remedied”
- “failed to complete the required number of audits for one-third of the States and did not always follow up on systemic problems”
According to OIG, “[t]he most common systemic problem was the inspectors’ failure to identify violations.” It appears that approximately 16% of inspectors reportedly had this type of deficiency. OIG’s findings are significant because, as of 2009, the majority of FDA’s food inspections were conducted by state inspectors.
The OIG report could lend further ammunition to those who question the reliability of non-FDA inspections and audits. Third-party auditors have repeatedly come under fire in the wake of recent outbreaks of foodborne illness, and are now being targeted in personal injury lawsuits.
Overall confidence in third-party audits could be bolstered by FDA’s implementation of the third-party auditor accreditation system authorized by FSMA. Although that system is expected to focus on imports, FDA has previously indicated that it might move toward recognition of third-party certification programs more generally (see our previous posting here). However, the OIG report suggests that the success of such efforts could turn on FDA’s own capacity as an auditor of auditors.