OIG Calls for Increased FDA Food Inspections and Expanded Penalties

By Ricardo Carvajal –

The Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services released a report that finds fault with FDA’s inspection activities for food facilities and recommends several changes, including an expansion of FDA’s statutory authority.  OIG reviewed FDA's food facility inspection activities between FY 2004 and FY 2008.  Among OIG’s findings:

• “On average, FDA inspected less than 25% of food facilities each year, and the total number of inspected facilities declined over time.”
• “56% of food facilities went 5 or more years without an FDA inspection.”
• In FY 2007, “FDA took regulatory action against 46 percent of the facilities with initial OAI classifications [an OAI or 'Official Action Indicated' classification means that objectionable conditions were found that might warrant regulatory action]; for the remainder, FDA either lowered the classification or took no regulatory action.”
• “For 36 % of the facilities with OAI classifications in FY 2007, FDA took no additional steps to ensure that the violations were corrected. For the remaining facilities, FDA took additional steps to ensure that the violations had been corrected. Specifically, FDA reinspected 35 percent of the facilities within a year of the initial inspection. For an additional 30 percent of facilities, FDA reported that it reviewed some type of evidence from the facility that demonstrated that the facility had corrected violations.”

For FY 2008, OIG also found that most of the facilities that received OAI classification had “a history of violations.”  Further, 2% of the facilities that received OAI classification refused FDA requests for access to records. 

Based on these findings, OIG recommended that FDA:

• “Increase the frequency of food facility inspections, with particular emphasis on high-risk facilities.”
• “Provide additional guidance about when it is appropriate to lower OAI classifications.”
• “Take appropriate actions against facilities with OAI classifications, particularly those that have histories of violations.”
• “Ensure that violations are corrected for all facilities that receive OAI classifications.”
• “Consider seeking statutory authority to impose civil penalties through administrative proceedings against facilities that do not voluntarily comply with statutory and regulatory requirements.”
• “Seek statutory authority to allow FDA access to facilities’ records during the inspection process.”

In its response, FDA noted that food safety legislation pending in Congress and supported by FDA would expand civil penalties for food-related violations and would expand FDA’s authority to access records, among other things.  As for its inspection activities, FDA has added nearly 700 field staff to its Foods Program since 2007, and the agency expects a corresponding increase in the number of food inspections; however, FDA noted that calls for increased inspections need to be backed by “a reliable, consistent funding source.”  FDA is also taking additional measures to enhance its inspections, most notably by conducting “intensive environmental sampling” intended to detect “unsuitable manufacturing conditions.” 

With respect to following up on findings of violation, FDA restated its commitment to the enforcement strategies outlined by Commissioner Hamburg in August 2009, including (1) establishing a timeframe for firms to submit responses to FDA findings, (2) streamlining Office of Chief Counsel review of warning and untitled letters, (3) prioritizing follow-up activities on warning letters and recalls with significant health implications, and (4) taking “swift, aggressive and immediate enforcement action in cases where significant health concerns or egregious violations are identified.”