FDA Food Safety Inspections of Domestic Food Facilities

Why OIG Did This Review

• Each year, roughly 48 million people in the United States get sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.
• To protect against foodborne illnesses, the Food and Drug Administration (FDA) inspects food facilities to ensure compliance with regulations and the safety of the Nation’s food supply.
• FDA must inspect facilities within required timeframes, either 3 or 5 years depending on the food safety risk of the facility.

What OIG Found

We found gaps in FDA’s efforts to inspect domestic food facilities, particularly in meeting required timeframes.

• FDA is conducting fewer inspections of food facilities compared to the number prior to the pandemic.
• FDA did not inspect many facilities within the required timeframes and is not inspecting enough facilities to meet the timeframes in the future.
• FDA attempted to inspect thousands of facilities that were not in operation, which created an inefficient use of resources.
• FDA uncovered significant violations in 1 to 2 percent of facilities inspected each year. FDA’s identification of significant violations has decreased steadily over time.
• For the majority of significant violations, FDA did not conduct timely followup inspections.

What OIG Recommends

These findings underscore the need for FDA to increase its efforts to inspect food facilities and meet required timeframes. If FDA does not address these concerns, it cannot identify harmful conditions and prevent facilities from producing and distributing unsafe food. OIG recommends that FDA:

1. Increase the number of facilities inspected each year and ensure that all facilities are inspected within the required timeframes;
2. Improve methods for identifying facilities that are not in operation to make better use of resources;
3. Assess reasons for the decrease in number of facilities inspected by FDA with significant violations and take action as appropriate; and
4. Conduct timely followup inspections of facilities with significant violations.

FDA concurred with all four of our recommendations.