The Foreign Supplier Verification Program hasn’t gotten much attention since going live in 2017, and it shows.
In its Inspection Observation Data report, the FDA’s Office of Regulatory Affairs (ORA) revealed that failing to draft an FSVP was the most frequently cited violation during FDA food facility inspections in 2019 with 340 violations.
The 2011 Food Safety Modernization Act (FSMA) mandates foreign supplier verification, which means importers have to comply with specific requirements to ensure suppliers are following the law and delivering items and ingredients safely. Since most FSVP compliance deadlines are now in effect, the FDA expects relevant importers to present their FSVPs upon request during inspections.
The FDA has found several FSVP-related violations, including:
Failing to follow or maintain the FSVP.
Failing to translate the FSVP into English when applicable.
Failing to sign and date the FSVP upon modification.
Failing to make adequate assurances of a supplier’s food safety.
The FDA issued its first FSVP warning letter in September 2019. “The warning letter follows an FDA inspection conducted in response to a Salmonella outbreak, which revealed that the importer was not in compliance with the FSVP,” then-acting Commissioner Dr. Ned Sharpless wrote when announcing the move. “The FDA continues to work with food importers that are developing plans to adhere to the FSVP regulation and work to comply. However, neglecting to meet the FDA’s food safety requirements puts consumers at risk, and our top priority is using the full range of our available tools to protect public health.”
The FDA has published a list of documents facilities should have on hand for an inspection to show FSVP compliance.
Other leading violations include:
Personnel (21 CFR 117.10) – This violation is for failing to take reasonable measures and precautions related to personnel practices. It can consist of not addressing hygiene issues or other suitable manufacturing practices concerning employees handling food products. The FDA issued 226 citations for this violation in 2019, a marked increase from 161 the year before.
Pest Control (21 CFR 117.35(c)) – The FDA cited 222 facilities in 2019 for not excluding pests from their facility or unlawfully utilizing pesticides; this is an increase from 183 citations issued the year before.
Sanitation Monitoring (21 CFR 120.6) – This citation is for a failure to monitor sanitation conditions and implement good manufacturing practices, including using unclean water for food production, having unclean food contact surfaces, allowing cross-contamination risks, and other poor sanitation practices. 195 facilities received sanitation monitoring citations in 2019, an increase from 188 the year before.
Sanitary Operations and Plant Maintenance (21 CFR 117.35(a)) – In 2019, 193 facilities received citations for failing to maintain their plant in a clean and sanitary condition or keeping the plant in good repair marking an increase from the year before of 167 citations.
Temporary FSVP Policy
In April 2020, while the pandemic disrupted business and regulatory activity across the board with travel restrictions, social distancing measures, and other limitations, the FDA announced it would halt routine inspections and instead require companies to submit compliance documentation electronically.
“Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make written requests for records,” the FDA announcement explained. “In rare situations, such as in response to an outbreak of foodborne illness, FDA may still choose to conduct an on-site FSVP inspection.”
In May, the FDA extended these measures and explained it was working on a phased plan with the CDC to reinstate on-site audits.
This temporary shift in regulatory policy is not a relaxation of the FSVP requirements. The FDA continues to check for documentation and issue warning letters. If anything, food and beverage manufacturers should be more diligent than ever due to new risks posed by the significant supply chain disruption caused by the pandemic.
If you want more details about this issue, check out our on-demand webinar. James Chu, FSVP Lead Instructor and Supplier Quality Manager at John B. Sanfilippo & Son provides expert insight on complying with the temporary FSVP policy update. You can watch the webinar here.