The U.S. Food and Drug Administration released its Inspection Observation Data for the Fiscal Year (FY) 2019. This data set includes violations cited during facility inspections from October 2018 through September 2019. Last year’s most commonly cited violation during food facility inspections was failing to develop a Foreign Supplier Verification Program (FSVP), with 340 violations. This article will discuss what FDA expects when conducting an FSVP inspection as well as other commonly cited food facility violations.
Under the Food Safety Modernization Act (FSMA), most food importers are required to develop and maintain FSVPs for their foreign suppliers. This requires importers to perform certain activities to ensure their suppliers are FDA compliant and producing goods in a safe and acceptable manner.
The vast majority of FSVP compliance deadlines have passed. FDA expects applicable importers to present their FSVPs upon inspection. In 2017, the first year after the initial deadlines, FDA cited 108 importers for failing to develop an FSVP. In 2018, FDA cited 289 importers for this violation. This past year, that number has jumped to 340 (a 17% increase).
Additionally, 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 supplier’s food safety
In total, 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. Registrar Corp’s Qualified Individuals can assist by developing or reviewing your FSVPs for FDA compliance. Another useful tool is Registrar Corp’s FDA Compliance Monitor, which alerts you to any past, current, and future food safety risks related to your suppliers. Schedule a demo to learn more.
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 measure and precaution 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. If your facility requires assistance with your HACCP Plan, Registrar Corp’s Qualified Individuals can assist in developing or reviewing your plan.
When 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. If you feel unprepared for an upcoming FDA inspection, Registrar Corp’s Mock FDA Inspection Service can help. Our food safety experts will visit your facility and give you a detailed report on what your facility needs to do to pass an FDA inspection.
Registrar Corp is a private company that assists business in complying with FDA regulations. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.