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FDA Inspections Under Scrutiny

GAO Report Highlights Deficiencies in FDA Inspection Program

A recent report from the US Government Accountability Office (GAO) has found that the Food and Drug Administration’s (FDA) inspection program is in need of improvement. The report, which was released on July 14, 2023, found that the FDA’s inspection program is not always effective in identifying and preventing safety problems with food, drugs, and medical devices.

The GAO report made a number of recommendations to the FDA, including:

Developing a more risk-based approach to inspections
Increasing the frequency of inspections
Improving the training of inspectors
Developing more effective enforcement strategies

The FDA has agreed to implement a number of the GAO’s recommendations. However, it is unclear whether the FDA will be able to fully address the concerns raised in the report.

The GAO report is the latest in a series of critical reports on the FDA’s inspection program. In 2022, the FDA’s Office of Inspector General found that the agency’s inspection program was not effective in preventing the sale of unsafe drugs.

The FDA’s inspection program has also been criticized by industry groups. In 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement saying that the FDA’s inspection program is “outdated and ineffective.”

The FDA’s inspection program is a critical part of the agency’s mission to protect the public health. However, the GAO report shows that the program is in need of improvement. The FDA must take steps to address the concerns raised in the report in order to ensure that the public is protected from unsafe food, drugs, and medical devices.