According to recently released Inspection Observation Data for the Fiscal Year (FY) 2019 from the Food and Drug Administration, most food importers are required to develop and maintain FSVPs for their foreign suppliers.
And the most commonly cited violation during FDA food facility inspections last year was failing to develop a Foreign Supplier Verification Program (FSVP), with 340 violations.
Foreign supplier verification is one of the mandates of the 2011 Food Safety Modernization Act (FSMA). This requires importers to perform certain activities to ensure their suppliers are FDA compliant and producing goods in a safe and acceptable manner.
According to Hampton, VA-based Registrar Corp., the vast majority of FSVP compliance deadlines have passed. FDA expects applicable importers to present their FSVPs upon inspection.
Register Corp. offers food sector companies assistance in passing FDA inspections and tracks FDA data.
In 2017, the first year after the initial deadlines, Register Corp. said FDA cited 108 importers for failing to develop an FSVP. In 2018, FDA cited 289 importers for this violation. This past year that number jumped to 340, a 17 percent increase.
Additionally, the FDA cited numerous facilities for other FSVP-related violations that include:
- 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
In total, Register Corp. reports FDA issued 354 citations for FSVP related violations.
“This significant increase in FSVP violations paired with the FSMA-related warning letters issued throughout the year points to a steady increase in FSMA enforcement from FDA. Being prepared is key to avoiding a citation,” it said.
Food Safety Violations
In addition to FSVP violations, FDA cited food facilities for other violations relating to food safety and good manufacturing practices. Here are the five most common from FY 2019:
- Personnel (21 CFR 117.10)- This violation is for failing to take reasonable measures and precautions related to personnel practices. This can include failing to address hygiene issues or other good manufacturing practices in relation to employees handling food products. FDA issued 226 citations for this violation, a marked increase from 161 the year before.
- Pest Control (21 CFR 117.35(c))- FDA cited 222 facilities for not excluding pests from their facility or for utilizing pesticides in unlawful manners. This is an increase from 183 citations from the year before.
- Sanitation Monitoring (21 CFR 120.6))- This citation is for a failure to monitor sanitation conditions and implement good manufacturing practices. These can range from failure to use clean water for food production, unclean food contact surfaces, cross-contamination risks, and other poor sanitation practices. 195 facilities received this citation, an increase from 188 the year before.
- Sanitary Operations and Plant Maintenance (21 CFR 117.35(a))- 193 facilities were cited for failing to maintain their plant in a clean and sanitary condition or keeping the plant in good repair. This also marks an increase from the year before at 167.
- HACCP Plan Implementation (21 CFR 123.6(c))- FDA cited 182 facilities for failing to implement either the monitoring, recordkeeping, or verification procedures listed on their HACCP Plans. HACCP Plans are required for most juice and seafood facilities.
When the FDA inspects a food facility, the agency will check for compliance with current good manufacturing practices and any other applicable food safety regulations. Failure to comply can result in FDA issuing warning letters, citations, or detentions.
For more information: www.registrarcorp.com/livehelp.