HAMPTON, VA. — Registrar Corp summarized the US Food and Drug Administration’s recently released Inspection Observation Data for 2020, showing the frequency of certain violations found during inspections from October 2019 to September 2020.

The No. 1 most common violation found by the FDA was for inadequate Foreign Supplier Verification Programs (FSVPs). The FDA requires importers to develop and maintain FSVPs for their suppliers to ensure continued compliance and safety.

The FDA expects to be presented with complete FSVPs, but cited 514 facilities over the year for failing to develop such a program. Although food facility inspections slowed in 2020 due to the COVID-19 pandemic, the FDA’s FSVP citations grew by 51% that year. This marks the third year in a row that FSVP citations have been the top-cited violation.FSVP violations 2017-2020

The second most common violation was for inadequate hazard analysis. The FDA cited 104 cases in which facilities provided incomplete hazard analysis, which helps them identify potential biological, chemical or physical hazards within a facility, as well as preventive controls for mitigating those hazards.

The third most common violation was pest control. The agency cited 98 facilities who failed to prevent pests from entering their food facility, or for misusing pesticide products that could lead to potential food contamination, Registrar Corp said.

Fourth on the list was manufacturing controls, which account for manufacturing, processing, packing and holding controls to minimize contamination by microorganisms, cross contamination or food deterioration. The FDA cited 95 facilities for manufacturing controls violations in 2020.

Lastly, the FDA issued 87 citations to food facilities based on personnel issues. These include hygiene issues and other good manufacturing practices related to employees who handle the food products.

While not among the top five most frequent citations, sanitation was also an issue in 2020. The FDA cited 81 seafood processing facilities for not properly monitoring sanitation practices. These violations regarded water that comes in contact with food, the condition of food contact surfaces, and hand-washing, hand-sanitizing or bathroom violations by employees.

Additionally, 80 facilities were cited for plant maintenance and sanitation issues, which is an environmental risk. The agency also cited 58 companies for failing to sanitize equipment.

The FDA issued 45 citations for inadequate sanitation of food contact surfaces, including utensils and other surfaces used in the preparation of food that were not properly cleaned.

Registrar Corp said compared to the previous year of inspections (October 2018 to September 2019), FSVP violations increased by 51%, but other top citations decreased. This was likely due to the pandemic’s impact on the FDA’s ability to conduct inspections in 2020. 

As we look to 2021, Registrar Corp suggested taking note of these high-frequency violations. The company offers a virtual Mock FDA Inspection Service, in which food safety experts can remotely help facilities prepare for a real FDA inspection.

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