HHS Inspector General Says FDA's Approach To Food Inspection Has Major Flaws
The federal Food and Drug Administration’s approach to executing one its most important duties- safeguarding our nation’s food supply, is flawed, according to the Office the Inspector General of the U.S. Department of Health and Human Services. (HHS)
Each year, 128,000 Americans are hospitalized and 3,000 die after consuming food or beverages contaminated with dangerous pathogens such as E.coli, Salmonella and Listeria.
To ensure that our food is safe, the FDA, an agency within HHS, must conduct inspections of food facilities nationwide. To do this, it relies upon the manpower of state employees, but this approach has created a series of problems, according to a recent report by the Inspector General.
“For example, the peanut processing plant responsible for a 2009 salmonella outbreak was inspected multiple times by a state agency working on behalf of FDA. This outbreak resulted in one of the largest food recalls in U.S. history and has led to serious questions about the effectiveness of state food facility inspections,” the report states.
In addition to poorly executed inspections, lack of consistency and followthrough are also problems. In eight states, for example, the FDA: failed to ensure that the required number of inspections was completed; paid for inspections that were incomplete; and did not ensure that all inspections were properly classified or that all inspection violations were remedied.
In some cases, FDA officials were often unclear about how to properly classify inspections conducted through contracts with states. In 11 states, FDA officials said they would not assign official action indicated (OAI) classifications to state inspections under any circumstances, contrary to FDA guidance, the report states. The OAI classification is generally assigned to cases where the most serious violations are identified.
When states do take responsibility for correcting violations, the FDA is not always notified and is therefore unable to check that inspection violations were remedied, the report states.
In 14 of 41 states with inspection contracts, the FDA also failed to complete the required number of audits. The FDA is required to conduct audits on a minimum of 7 percent of a state's contract inspections each year, the report states.
The Inspector General made the following recommendations:
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.
5 Address any systemic problems identified by audits.
The FDA concurred with four of the recommendations and agreed in part with the fifth.
