The Office of the Inspector General (OIG) has found that the U.S. Food and Drug Administration (FDA) domestic food inspections “did not always take action when it uncovered significant inspection violations-those found during inspections classified as ‘Official Action Indicated’ (OAI). When it did take action, it commonly relied on facilities to voluntarily correct the violations. Also, it rarely took advantage of the new administrative tools provided by the Food Safety Modernization Act (FSMA). Moreover, FDA actions were not always timely nor did they always result in the correction of these violations. Further, FDA consistently failed to conduct timely follow-up inspections to ensure that facilities corrected significant inspection violations.”
The new OIG report discloses FDA’s spending on domestic food facility inspections from 2004 to 2015. Data analyses show spending on domestic food inspections has dropped off in the years since the passage of FSMA.
The OIG made the following recommendations:
- FDA should improve how it handles attempted inspections to ensure better use of resources.
- FDA should take appropriate action against all facilities with significant inspection violations.
- FDA should improve the timeliness of actions, including warning letters so that facilities do not continue to operate under harmful conditions.
- FDA should conduct timely follow-up inspections to ensure that significant inspection violations are corrected.
FDA defended the use of its regulatory powers, pointing out that it suspended the registration of SM Fish in September 2016 and Dixie Dew Products Inc. in March 2017. In their response to the OIG report, FDA leaders said they recognize the need to “improve the timeliness of regulatory actions.”
The agency also explained its need to change with the market. It established the Office of Dietary Supplement Programs (ODSP) in 2015 after sales of dietary supplements grew to $40 billion a year, up from just $4 billion two decades earlier. Beyond six months, 65 percent of FDA’s warning letters addressed dietary supplement concerns.
As for correcting violations, FDA said its goal is “to conduct timely follow-up inspections to ensure that significant violations are corrected.” The food safety agency a “multi-programmatic oversight group” to make sure food makers correct violations.