FDA Inspector General Report on Progress of FSMA Inspections

On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on the agency’s domestic food facility inspections: Challenges Remain in FDA’s Inspections of Domestic Food Facilities (the Report).  The Report concluded that FDA is on track to meet the initial domestic food facility inspection timeframes mandated by the Food Safety Modernization Act (FSMA).  But the Report’s key takeaway was: “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.”

This blog summarizes the key points of the Report.

Study Findings

To prepare the Report, OIG analyzed data from four sources: (1) Information about facilities that FDA designated high risk and non-high risk pursuant to FSMA, and whether these facilities were inspected as required; (2) FDA’s food facility inventory and inspection data from 2010 to 2015; (3) Information about FDA’s advisory and enforcement actions, such as warning letters and seizures, taken in response to significant inspection violations, as well as whether follow-up inspections were conducted for these violations, and; (4) Structured interviews with FDA officials.

The key findings of the report included:

  • FDA is on track to meet the domestic food facility inspection timelines for the initial inspection cycles mandated by FSMA; however, challenges remain as FSMA requires FDA to conduct future inspections in timeframes that are 2 years shorter than the timeframe for the initial cycles.

Under FSMA, all facilities deemed “high risk” are required to receive an initial inspection within 5 years; these facilities must be inspected every 3 years thereafter.  All other facilities are required to receive an initial inspection within 7 years, and every 5 years thereafter.  The Report indicates that FDA inspected all but nine of the high-risk facilities and the agency is on pace to meet its deadline with respect to non-high-risk facilities.  OIG gave FDA high marks for its pace of inspection on high-risk facilities and determined that the agency is likely to meet the deadline for the next inspection cycle.   However, with respect to non-high-risk facilities, FDA will need to increase its pace of inspections to meet its obligations during the next inspection cycle.

  • Inaccuracies in FDA’s 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.

FDA expended considerable resources on attempted investigations that never occurred because the facility was no longer in business or not operational at the time of the planned inspection.  More than one-quarter of the high-risk and non-high-risk facilities that FDA counted towards its inspection mandate were either out of business or not in operation at the time of the unplanned inspection.  FDA does not currently have a policy in place to reschedule inspections at seasonal facilities that were not in operation at the time of the initial attempt to conduct an unplanned inspection.

  • The overall number of facilities inspected annually decreased over the time of the study. The number of facilities inspected fell from a high of 19,000 in 2011 to 16,000 in 2015.

The number of facilities inspected by FDA actually decreased over the course of the initial inspection cycle.  OIG is concerned because the number of food establishments requiring inspection is increasing, but the decreased pace in inspections mean facilities face less FDA oversight.  In 2004, FDA inspected 29 percent of establishments in a given year, whereas FDA only inspected 19 percent of facilities in 2015.

  • FDA did not always take action when it uncovered significant inspection violations (inspections classified as “Official Action Indicated” or “OAI.”). When FDA did take action, it commonly relied on facilities to take undertake voluntary corrections.

The Report calls for more enforcement actions in response to significant inspection violations. When FDA inspections reveal significant inspection violations and assigns an OAI classification, OIG states that an advisory action or enforcement action is warranted to ensure food produced by these facilities is safe.  FDA uncovered significant inspection violations in 1 to 2 percent of facilities it inspected each year.  According to the Report, FDA took no advisory or enforcement actions in response to 22 percent of the significant inspection violations that occurred from 2011 to 2015.  When the agency initiated action in response to these violations, FDA chose advisory action 73 percent of the time (e.g., warning letters, untitled letters, or regulatory meetings).

  • FDA did not take advantage of the new administrative tools provided by FSMA.

FSMA empowered FDA by easing the criteria for administratively detaining potentially unsafe food, mandatory recall authority, and allowed FDA to suspend the registration of a facility and prohibit that facility from distributing food.  From 2011 to 2015, FDA issued an administrative detention order five times and twice suspended facility registrations.  FDA did not issue any mandatory recalls in response to significant inspection violations.  The Report criticizes the agency for not taking advantage of this new authority; however, in practice many facilities will perform voluntary corrective actions or recalls because it is understood that FDA possesses this authority.

  • FDA’s actions were not always timely nor did they always result in the correction of these violations.

FDA’s goal is to issue all warning letters within 4 months of the end of inspection or the return of a positive sample.  However, from 2011 to 2015, FDA missed this timeframe with respect to half of all warning letters.  Moreover, 20 percent of warning letters were not delivered until after six months and 2 percent took longer than a year.  OIG is concerned that this delay will allow facilities to continue to operate with potentially unsafe or unsanitary conditions.  Moreover, one in five facilities with OAI classifications that were subject to an advisory action resulted in a second OAI classification during reinspection.  Of these facilities receiving a second OAI classified inspection, three quarters received their second OAI classification for the identical problem underlying their first OAI classification.

  • FDA consistently failed to conduct timely follow-up inspections to ensure that facilities corrected significant inspection violations.

The Report concluded that FDA did not conduct a timely follow-up inspection on almost half of significant inspection violations from 2011 to 2015.  31 percent of facilities with significant inspection violations did not receive a follow-up inspection within a year; 17 percent of facilities with significant inspection violations received no follow-up inspections.

Study Recommendations

In the Report, OIG offers four recommendations for FDA to improve the effectiveness of its domestic facility program:

  • Improve how the agency handles attempted inspections to ensure better use of resources.

OIG recommends that FDA improve its database of facilities to ensure the accuracy of information about facilities requiring inspection.  This would result in fewer resources devoted to attempting inspection at facilities that are out or business or not in operation.

  • Take appropriate action against all facilities with significant inspection violations.

OIG recommends that FDA take the most effective action to achieve compliance and initiate administrative or judicial actions against facilities that do not voluntarily comply.  OIG also recommends making further use of the administrative tools provided under FSMA.

  • Improve the timeliness of FDA’s actions so that facilities do not continue to operate under harmful conditions.

OIG recommended that FDA initiate regulatory actions promptly in response to facilities with significant inspection violations found during OAI classified inspections, including issuing warning letters on a timely basis.

  • Conduct timely follow-up inspections to ensure that significant inspection violations are corrected.

OIG recommends FDA improve on its timeliness of follow-up inspections to ensure that food safety hazards and unsafe or unsanitary conditions do not persist.

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