The FDA’s Inspection Observation Data for the Fiscal Year (FY) 2020, depicting how frequently particular violations were found during food facility inspections between October 2019 and September 2020, are out.

Hampton, VA-based Registrar Corp. did this breakdown of the data from the Food and Drug Administration and provided analysis of the top five violation categories cited by FDA inspectors during FY 2020:

1. Foreign supplier compliance programs
Under the Food Safety Modernization Act (FSMA), FDA requires most food importers to develop and maintain Foreign Supplier Verification Programs (FSVPs) for their suppliers. The requirement is designed to help ensure that suppliers are FDA compliant and are producing food in a safe manner. 

During FSVP inspections, the FDA expects importers to present complete FSVPs that adequately assure suppliers’ food safety. In FY 2020, the FDA cited 514 facilities for failing to develop an FSVP. While most food facility inspections were halted for the majority of 2020 because of the COVID-19 pandemic, the FDA continued to conduct FSVP inspections remotely. FSVP citations increased by 51 percent compared to 2019. This is the third year in a row that failure to develop an FSVP was the top-cited inspection violation. 

2. Hazard analysis
In 2020, the FDA cited 104 cases where facilities failed to provide adequate hazard analysis. The agency requires most food facilities to identify potential biological, chemical, or physical hazards that may occur at the facility as well as establish preventive controls for those hazards. This is another way the FDA ensures that facilities are maintaining food safety protocols.  

These hazards can vary. For example, a facility can identify that it is possible for pathogens to survive processing intended to eliminate them. Alternatively, the facility can identify areas where inadequate cleaning of equipment can lead to allergen cross-contact. 

3. Pest Control
During facility inspections, the FDA inspectors search for signs of potential pest infestations. The FDA cited 98 facilities for failure to prevent pests within their food facility or for misusing pesticides in a way that could cause potential food contamination. 

4. Manufacturing controls
Manufacturing, processing, packing, and holding controls account for 95 of 2020’s food facility citations. This citation indicates that a facility did not conduct operations under conditions that would minimize the chances for potential microorganism growth, allergen cross-contamination, or contamination and deterioration of food. FDA requires facilities to provide controlled environments when handling food products to avoid potential health risks to consumers. 

5. Personnel
The fifth most cited violation during food inspections in FY 2020 were personnel issues. These can include failing to address hygiene issues or other good manufacturing practices in relation to employees’ handling of food products. The FDA issued 87 citations for this violation. 

Sanitation citations
While no sanitation citations made it into the top five on their own, sanitation citations make up a significant portion of the FY 2020 violations when combined with other violations. For example: 

  • FDA cited seafood processing facilities 81 times for failure to properly monitor their sanitation practices. These could include, but are not limited to, not properly monitoring “safety of the water that comes into contact with food, condition and cleanliness of food contact surfaces,” or “maintenance of handwashing, hand sanitizing, and toilet facilities.” 
  •  FDA cited 80 facilities for plant maintenance and sanitation issues. These are the result of failing to maintain a clean and sanitary food facility, which can also pose environmental threats to food products. FDA cited facilities for failing to sanitize their equipment 58 times. 
  •  FDA cited facilities 45 times regarding sanitation of food contact surfaces. This usually means that utensils and surfaces used in food preparation were not properly cleaned to prevent product contamination. 

Preparing for FY 2021
While FSVP violations saw a significant increase, the other top citations were issued fewer times in FY 2020 than in FY 2019. This is likely because of the temporary postponement of most food facility inspections in 2020 as a result of COVID 19.

For 2020, FDA food facility registrations totaled 241,567 worldwide. Registrations for 2021 are off about 25 percent at 182,147.

 Registrar Corp.’s food safety experts help companies pass facility inspections and comply with other FDA regulations.

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