The U.S. Food and Drug Administration (FDA) released its annual Inspection Observation Data for the Fiscal Year (FY) 2021. This data depicts how frequently FDA cited particular violations during food facility inspections between October 2020 and September 2021.

Read on to learn about the top 5 violations that FDA inspectors cited in FY 2021.

1. FSVP Violations

Under the Food Safety Modernization Act (FSMA), FDA requires most food importers to develop and maintain Foreign Supplier Verification Programs (FSVPs) for their suppliers. This requirement helps FDA verify that a facility’s foreign suppliers are producing food that is compliant with FDA’s food safety requirements.

During FSVP inspections, FDA requires importers to present complete FSVPs that adequately demonstrate suppliers’ food safety. In FY 2021, FDA cited 796 facilities for failing to develop an FSVP, a 55% increase from FY 2020. This is the fourth consecutive year that failure to develop an FSVP was the top cited inspection violation.

Registrar Corp can help you prepare for an FSVP inspection by assisting with developing and maintaining FSVPs. We also offer a 100% online, self-paced course on FSVP.

2. Pest Control

During facility inspections, FDA searches for signs of potential pest infestations. In FY 2021, FDA cited 88 food facilities for failure to use effective measures to exclude pests within the facility. This citation can also indicate a facility is misusing pesticides in a way that could cause potential contamination of food, food-contact surfaces, and food-packaging materials.

Do you know the specifics of FDA’s pest controls regulations? Build your knowledge with our RegiLearn course on pest control.

3. Manufacturing Controls

Manufacturing, processing, packing, and holding controls account for 84 of FY 2021’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.

Strengthen your understanding of manufacturing controls with our RegiLearn courses on Listeria, preventing contamination, and more. You can also complete our online allergen training to learn about the foundations and control measures of allergens.

4. Hazard Analysis

FDA requires most food facilities to identify potential biological, chemical, or physical hazards that may occur at their facility and establish preventive controls for those hazards. For example, a facility can identify that it is possible for pathogens to survive processing intended to eliminate them. In FY 2021, FDA cited 83 cases where facilities failed to provide an adequate hazard analysis.

Does your facility have a trained PCQI (Preventive Qualified Individual) conducting your Hazard Analysis and writing your Food Safety Plan? This is required by the FSMA Rule. Get the training you need to become a certified PCQI with our online PCQI training course.

5. Sanitary Operations

Food facilities must maintain a clean and sanitary facility to prevent environmental threats to food products. During an inspection, FDA assesses whether a firm is adequately repairing and sanitizing every physical aspect of the facility to prevent food adulteration. FDA gave 70 citations for violations regarding plant maintenance sanitary operations in FY 2021.

Need to refresh your knowledge of sanitary operations? Take our online training for Sanitation Practices.