FDA Inspections Face Challenges, Says Inspector General

In News, Regulatory by Krista Garver0 Comments

FSMA is supposed to bring more, and more intense, FDA inspections of domestic food facilities. But, according to a report by the Office of the Inspector General (OIG), the FDA has some work to do to make sure that food facility inspections are performed and, more importantly, that violations are corrected.

The OIG looked at data from inspections that occurred between 2010 and 2015, before the first FSMA deadline rolled around. They also examined what happened following those inspections.

The results show that FDA inspections and followup actions were often insufficient, even before FSMA. Specifically, the analysis showed that:

  • The number of food facilities inspected decreased over time.
  • The FDA often worked with inaccurate data, which resulted in inspectors showing up to facilities that were out of business or not in operation.
  • The FDA didn’t always take action in response to significant violations. When they did, those actions weren’t timely and often relied on companies to fix problems voluntarily. As a result, the violations weren’t always corrected.
  • The FDA “consistently failed to conduct timely followup inspections,” even after significant violations were found.

To correct these problems, the OIG recommended that the FDA:

  • Improve its process
  • Take appropriate action when significant violations are found
  • Take timelier action
  • Conduct timelier followup inspections

Despite the problems, the OIG says that FDA is still on track to meet FSMA timeframes, which mandates inspection cycles that are two years shorter than previously required.

In other FDA news, the agency finally settled the age-old question about whether food can be made with love. It can’t.

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