What OIG Found
FDA is on track to meet the domestic food facility inspection timeframes for the initial cycles mandated by FSMA; however, challenges remain as FSMA requires FDA to conduct future inspections in timeframes that are 2 years shorter than the timeframes for the initial cycles. Also, inaccuracies in FDA’s domestic food facility data result in FDA attempting to inspect numerous facilities that are either out of business or otherwise not in operation at the time of the visit.
Although FDA is on track to meet the FSMA inspection mandates during the initial cycles, theoverall number of food facilities that FDA inspected since the passage of FSMA has decreased from a high of about 19,000 facilities in 2011 to just 16,000 facilities in 2015.
In addition, FDA 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 FSMA.
Moreover, FDA’s actions were not always timely nor did they always result in the correction of these violations. FDA consistently failed to conduct timely followup inspections to ensure that facilities corrected significant inspection violations. For almost half of the significant inspection violations, FDA did not conduct a followup inspection within 1 year; for 17 percent of the significant inspection violations, FDA did not conduct a followup inspection of the facility at all.
What OIG Recommends
We recommend that FDA (1) improve how it handles attempted inspections to ensure better use of resources, (2) take appropriate action against all facilities with significant inspection violations, (3) improve the timeliness of its actions so that facilities do not continue to operate under harmful conditions, and (4) conduct timely followup inspections to ensure that significant inspection violations are corrected. FDA concurred with all four recommendations.