By Riëtte van Laack –
On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on FDA’s domestic food facility inspections. The “key takeaway”: “FDA should do more to ensure that the food supply is safe by taking swift and effective action to ensure the prompt correction of problems identified at domestic food facilities.”
In the previous (2010) review, OIG found that FDA inspected less than a quarter of domestic food facilities each year, and that many facilities had not been inspected in 5 years or more. OIG also found that FDA did not always take action against facilities with significant inspection violations or take steps to ensure the violations were corrected. According to the 2017 OIG report, two key recommendations from OIG’s 2010 review remain outstanding, i.e., (1) take appropriate action against facilities with significant inspection violations and (2) ensure that those facilities correct the violations.
FSMA requires FDA to increase the frequency of its inspections of domestic food facilities. Specifically, FSMA mandates that FDA inspect high-risk facilities at least once during the initial 5-year inspection cycle and then at least once every 3 years for subsequent cycles. (A facility would be high risk based on a number of factors including association with outbreaks, recalls or prior food safety related violations.) For the remaining facilities, the non-high risk facilities, FSMA requires that FDA inspect them at least once during the 7-year initial inspection cycle and at least once every five years for subsequent cycles. Prior to FSMA, there were generally no timeframes for food facility inspections.
While executing its inspection plan, FDA discovered that information about food establishments was not always up-to-date or sufficient. For a not-insignificant percentage (more than 25%) of the facilities, FDA’s inspection failed because the facility was either out of business or otherwise not in operation at the time of the visit. These failed inspections were counted as completed inspections. OIG determined that FDA has no policy to assure that such inspections do occur.
OIG determined that FDA is on track to meet the requirements for the first round of inspections (for the high risk facility inspections, FDA is in fact ahead of the schedule as it completed inspections for almost all those facilities within three years). FDA likely can meet the requirement for the second round of inspections of the high-risk facilities (to be completed within three years). However, OIG questions the Agency’s ability to meet the second (5-year) inspection cycle for the non-high-risk facilities.
OIG further determined that FDA uncovered significant (official action indicated or OAI) violations in one to two percent of the inspected facilities. In 22% of those instances, FDA allegedly did not take any action. Moreover, in the instances that FDA did take action, FDA “commonly relied on facilities to voluntarily correct [the] . . . violations” in response to a Warning Letter, Untitled Letter or similar action by FDA. According to OIG, FDA actions were “not always timely.” In the period from 2011 to 2015, FDA took 1,113 “advisory actions” consisting of 903 warning letters, 136 regulatory meetings, and 74 “untitled letters.” Those actions were taken (on average) 4.4 (warning letters and meetings) to 6.1 months (untitled letters) after an inspection.
OIG further determined that in the five-year period, FDA ordered a suspension of a food facility twice (0.8 months after the inspection) and five administrative detention orders (0.2 months after the inspection). FDA sought judicial action 58 times, and won seizure orders in 21 instances. OIG noted that FDA did not use its mandatory recall authority. Of course mandatory recall is not needed if companies recall products when asked by FDA.
For almost 50% of the OAI inspections, FDA did not conduct a follow-up inspection within 1 year and for 17% of the OAI inspections, FDA did not conduct a follow-up inspection of the facility at all. In cases that FDA did a reinspection, one in five facilities received a second OAI classification. Three quarters of these second OAI classifications involved the same problem that caused the first OAI classification.
OIG recommend 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 actions, including warning letters; and
conduct timely follow-up inspections to ensure that significant inspection violations are corrected.
FDA’s written responses and explanations are in the OIG report. FDA generally concurs with the OIG recommendations.
A major goal of FSMA is to be preventive rather than reactive. During the five-year period studied by OIG, the majority of food facilities were not yet subject to the preventive control regulations. It will be interesting to see how the implementation of these requirements affects FDA inspections and compliance.