FDA reviews inspection activity at FSPCA conference

By David Fairfield, Senior Vice President, Feed

U.S. Food and Drug Administration (FDA) officials reviewed Food Safety Modernization Act (FSMA)-related inspection activity and outlined future compliance initiatives during this week’s Food Safety Preventive Controls Alliance’s (FSPCA) annual conference.

Glenn Bass, FDA deputy director of human and animal food operations – west, and John Verbeten, FDA acting deputy director of the Office of Enforcement and Import Operations, were keynote presenters during the virtual conference conducted on Dec. 8 and 9, and provided the following insights about the agency’s inspections and compliance activities.

• Number of Inspections: Given the COVID-19 pandemic, the number of human and animal food facility inspections conducted to evaluate compliance with FSMA regulations for current good manufacturing practice (CGMP), preventive controls (PC) and sanitary transportation during fiscal year (FY) 2020 (Oct. 1, 2019 through Sept. 30, 2020) was significantly lower than the agency planned. However, inspections for FDA’s foreign supplier verification program (FSVP) rule generally proceeded as planned during FY 2020 because the rule requires importers to provide records in an electronic format to FDA for remote review to evaluate compliance and take enforcement action, if necessary.

The tables (pictured right) provide detailed information on the number of inspections conducted by FDA during recent fiscal years.

Regarding future facility inspections, FDA estimated it would conduct 8,000 domestic food inspections and 1,400 foreign food inspections when requesting budget appropriations for FY 2021. This anticipated level of activity would correspond closely to the number of inspections conducted during FY 2018 and FY 2019, but the actual number of facility inspections conducted during FY 2021 will be influenced significantly by COVID-19 test positivity rates. FDA on July 10 announced the agency would conduct routine inspections at domestic facilities in accordance with the White House Guidelines for Opening Up America Again, as well as the Centers for Disease Control and Prevention (CDC) guidance for protecting workplace exposures. FDA is continuing to schedule its field activities based on these guidelines.

• Inspection Classifications: Current inspection classifications reflect the agency’s approach to “educate before and while we regulate” when conducting initial inspections related to new requirements established under FSMA. However, in FY 2021 and beyond, the agency likely will rely more frequently on enforcement action to promote compliance.

Click to view the following tables, which detail FDA’s animal food inspection classifications and most frequent citations. (FDA Inspections – Most Frequent Animal Food Citations and FDA Animal Food Inspection Classifications)

• FDA Food Safety Dashboard: FDA-TRACK: Food Safety Dashboard is the agency’s performance management system that monitors FDA Centers and Offices through key performance measures and projects. The dashboard is accessible publicly and may be queried to obtain a variety of information about FDA’s activities associated with preventive controls and current good manufacturing practice and imported food safety  
• Remote Regulatory Assessments: During FY 2020, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) initiated a program in which human food facilities could voluntarily participate in remote regulatory assessments. While FDA’s FSMA regulations generally provide the agency with authority to request and review required records only during an in-person facility inspection (with the exception of the FSVP rule), human food facilities voluntarily choosing to participate in the new program remotely share with the agency required records associated with its compliance obligations to allow FDA staff to evaluate the records outside of an actual facility inspection.

According to FDA, benefits associated with the remote regulatory assessment program include more efficient use of agency resources, decreased time required during subsequent in-person inspections at the participating facility, and the potential opportunity for the facility to make corrections in response to the record review prior to an actual inspection taking place. Significantly, FDA characterizes the new program as an “assessment,” and not an “inspection.” This distinction indicates that FDA generally does not have legal authority to take enforcement action based upon remote review of records, and instead is required to rely on observations made during facility inspections to support enforcement actions taken. 

A remote regulatory assessment program currently is under development within FDA’s Center for Veterinary Medicine (CVM). It is anticipated that CVM’s program will be announced to the animal food industry during the first calendar quarter of 2021, and initially will focus on CVM’s VFD regulations that primarily require affected entities to establish and maintain records to demonstrate compliance.

• CVM Comprehensive Compliance Program: CVM said it expects to release its new comprehensive animal food compliance program in January 2021. The compliance program will detail CVM’s approach to conduct comprehensive inspections that address all applicable program areas that apply to a given facility during a single inspection. CVM’s program areas related to animal food include: 1) FSMA CGMP and PC requirements; 2) VFD regulations; 3) medicated feed manufacturing; 4) bovine spongiform encephalopathy (BSE)/ruminant feed ban requirements; 5) CGMP for type A medicated articles; and 6) feed contaminants.