Are You PreparedFor A U.S. FDA Inspection?
When you register with the U.S. Food and Drug Administration (FDA), you consent to an FDA inspection at any time. FDA may choose to conduct a routine inspection of a facility based on a number of factors, including the facility’s proximity to another the Agency intends to inspect.
Registrar Corp can dispatch a Food Safety Specialist to help your facility prepare for an FDA inspection.
What To Expect From An FDA Inspection
An FDA inspection can last anywhere between 2 and 5 days. During this time, the inspector may assess your facility’s compliance with:
FDA-registered food facilities must follow Current Good Manufacturing Practices (CGMPs) that address aspects such as:
- Plant Construction and Upkeep
- Employee Hygiene
- Manufacturing Operations
The Preventive Controls rules require facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) plans, which include aspects such as:
- An analysis of known and reasonably foreseeable food hazards
- Preventive controls for identified hazards
- Adequate monitoring procedures for preventive controls
FDA often cites facilities for failing to monitor sanitation conditions with sufficient frequency, such as water safety, prevention of cross-contamination, and maintenance of hygiene facilities.
FDA often cites facilities for not properly excluding pests that could potentially contaminate food.
Manufacturing, Processing, Packing, and Holding Controls
FDA may cite a facility for not implementing proper controls to mitigate the risk of food hazards, such as growth of microorganisms, allergen cross-contact, and food contamination.
Sanitary Operations and Plant Maintenance
FDA may cite a facility for either not maintaining the cleanliness of the plant or not keeping it in good repair.
FDA often cites facilities for not taking reasonable personnel measures and precautions, which may include failing to address staff hygiene and cleanliness.
Registrar Corp Makes Compliance Easy
Registrar Corp can dispatch a Food Safety Specialist to help you prepare for an FDA inspection.
Registrar Corp’s Mock FDA Inspection Service includes:
A complete review of your food safety documentation
A thorough assessment of your facility’s compliance with regulatory requirements
Virtual or onsite expert assistance from a Food Safety Specialist