i- A recently released Office of the Inspector General (OIG) report has found that the U.S. Food and Drug Administration (FDA) is making steady progress on its implementation of the Food Safety Modernization Act (FSMA) with specific regard to inspections of domestic food facilities, but challenges remain.
- In particular, the OIG found, in part, that:
- Although FDA is on track to meet the FSMA inspection mandates, this did not result in a greater number of facilities being inspected;
- FDA did not always take action to ensure that facilities corrected significant inspection violations;
- When FDA did take action, it most commonly relied on facilities to voluntarily correct significant inspection violations; these actions were not always timely nor did they always result in the correction of these violations; and
- FDA did not consistently conduct timely follow-up inspections to ensure that facilities had corrected significant inspection violations.
- OIG recommends that FDA:
- Improve how it handles attempted inspections to ensure better use of resources;
- Take appropriate action against all facilities with significant inspection violations;
- Improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions; and
- Conduct timely follow-up inspections to ensure that significant inspection violations are corrected. FDA concurred with all four recommendations.
- FDA concurs with all four recommendations.
OIG: “Challenges Remain in FDA’s Inspections of Domestic Food Facilities”
Monday, October 2, 2017
