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Top 5 FDA Inspection Violations in 2022

Jan 20, 2023

The U.S. Food and Drug Administration (FDA) released its annual Inspection Observation Data for the Fiscal Year (FY) 2022. This data depicts how frequently FDA cited violations during food facility inspections between October 2021 and September 2022.  

Here are the top 5 violations cited in the FDA Inspection Classification Database in FY 2022. 

Need Help Preparing for an FDA Inspection? Request an FDA Food Facility or FSVP Mock Inspection today.

Registrar Corp‘s Food Safety Specialists can help you prepare for an FDA inspection or an FSVP inspection 

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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  1. FSVP Violations

Of 852 FSVP inspections, 727 importers had not developed an FSVP. That accounts for 85% of inspected importers, making FY 2022 the fifth consecutive year that “failure to develop an FSVP” was the top cited FDA inspection violation. Most U.S. food importers must develop Foreign Supplier Verification Programs (FSVPs) for every foreign supplier per product they import. FDA requires FSVPs so importers provide adequate assurances that their foreign suppliers are producing food that meets FDA’s public health protection standards (21 CFR 1.502(a)).   

Actions an importer must take to provide these assurances may include the following, unless an exemption applies:  

  • Determining known or reasonably foreseeable hazards with each food 
  • Evaluating a food’s risk based on the hazard analysis and the supplier’s performance for granting approval 
  • Importing from approved suppliers only   
  • Conducting supplier verification activities 
  • Conducting corrective actions 
  • Having written FSVP procedures 
  • Designating a qualified individual to perform FSVP activities 
  • Identifying themselves as the FSVP Importer at customs entry 

Importers must keep records of FSVP activities for at least two years. 

Navigating FSVP compliance can be challenging, so it’s important that importers have rigorous standards in place that meet or exceed the requirements should FDA conduct an FSVP inspection. 

Importers that are not FSVP compliant could be added to Import Alert 99-41, which subjects the FSVP offenders’ imports to the U.S. to Detention Without Physical Examination (DWPE).   

Need assistance developing and maintaining FSVPs? Find out how our training, software, and consulting solutions can help you achieve and maintain FSVP compliance.

  1. Pest Control  

FDA cited 171 facilities as not having proper pest control procedures and/or failing to apply properly apply pesticides to protect against food contamination.  

Companies must take effective measures to exclude pests from their food facilities and contaminating food (21 CFR 117.35(c)). 

Pesticide use is permitted, but only under certain precautions and restrictions. These safeguards must prevent pesticides from contaminating the food, food-contact surfaces or materials used to pack food.  

  1. Sanitary Operations 

FDA cited 162 facilities as failing to keep their facility in a clean, sanitary, or adequately repaired condition. 

Food facilities must be maintained in sanitary conditions and undergo regular repairs to prevent adulteration of food (21 CFR 117.35(a)). Sanitation operations and repairs must extend to the building, fixtures, and any other physical part of the facility. Utensils and equipment must also be cleaned and sanitized to prevent cross-contamination or allergen cross-contact.  

Not sure what FDA defines as a sanitary food facility? Find out with our Sanitation Practices Online Training. 

  1. Manufacturing Controls

155 facilities failed to conduct operations in a controlled environment that would prevent certain public health risks. This includes potential microorganism growth, allergen cross-contact, contamination, and food deterioration. These observations can be associated with exposing packaging materials or the food to contamination, lack of allergen controls, subjecting food to temperature abuse, not maintaining adequate moisture levels when handling low moisture foods, not implementing proper process controls for application of heat treatments or for the acidification of a food, or not utilizing water of sanitary quality when using ice.  

  1. Personnel Practices 

FDA cited 151 facilities for failing to take measures that ensured personnel was safely handling food. These citations indicate a facility did not apply adequate disease controls or personnel cleanliness measures (21 CFR 117.10).  

If an individual has a health condition that could contribute to cross-contamination, such as an open lesion or infected wound, the person must be removed from food handling operations that could cause the food to become contaminated.  

Everyone in direct contact with food, food-contact surfaces, and food-packaging materials must observe hygiene practices that prevent allergen cross-contact and contamination, including:  

  • Wearing suitable outer garments  
  • Practicing sufficient personal hygiene  
  • Thorough handwashing 
  • Removal of loose objects that could fall into food, such as jewelry  
  • Maintaining cleanliness of gloves, if used 
  • Restraining or covering hair, when appropriate 
  • Storing personal items in designated areas, away from exposed food or areas where utensils and equipment are washed 
  • Smoking, eating, chewing gum, etc. away from exposed food or areas where utensils and equipment are washed 

Prepare Now for an FDA Inspection  

Companies can use information included in the FDA Inspection Classification Database to avoid food safety mistakes facilities commonly make.  An FDA facility inspection is thorough, and observations are used to determine if a company should take further action to address public health concerns their procedures may pose. It’s important for companies to understand potential violations and make necessary corrections to avoid inspection citations.  

Need Help Preparing for an FDA Inspection? Request an FDA Food Facility or FSVP Mock Inspection today.

Registrar Corp‘s Food Safety Specialists can help you prepare for an FDA inspection or an FSVP inspection 

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

Get Assistance Today

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Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

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