Every year, millions of Americans get sick—and some even die—because of foodborne diseases, according to the Centers for Disease Control and Prevention. With the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) is on a mission to prevent foodborne illness. For food producers, that means you’d better expect—and prepare for—scrutinizing inspections.
The good news is you can be prepared! In fact, you can ace an FDA inspection by following the very checklist the agency uses to spot your deficiencies, affirms regulatory compliance expert Angela Bazigos. In her audio conference for ProfEdOnDemand, “Prepare for an FDA Food Facility Inspection: Virtual Boot Camp,” Bazigos walks you through the FDA’s oversight program and teaches you how to comply with the agency’s laws and regulations. She’ll also instruct you on what to do when problems emerge.
3 Phases Of An FDA Inspection
With routine inspections on the rise, you can anticipate an inspection in your food facility. But you don’t have to dread the visit when you know what inspectors are looking for and how you can prepare your facility.
“During these visits, FDA is conducting lengthy facility inspections, comprehensive records reviews, and intense microbiological sampling of ingredients, finished products, and the food processing environment.,” states the Food Industry Counsel. The Counsel offers an inspection preparation checklist and breaks the inspection into 3 phases, including:
Phase 1: Facility inspection. FDA Investigators will tour and carefully inspect the processing and other areas of the facility.
Phase 2: Records review. FDA Investigators will carefully scrutinize the company’s written food safety programs, and at least three months of monitoring and verification records.
Phase 3: Swab-a-thon. FDA investigators will collect approximately 100 to 200 microbiological samples from incoming ingredients, outgoing finished products, and Zone 1, Zone 2, Zone 3 and Zone 4 environments.
10 Dos And Don’ts For Inspection Day
Even with an understanding of food safety basics and how food inspections are conducted, you can still easily blow an inspection if you step out of line with an inspector.
Keep anxiety at bay by remembering these dos and don’ts from Compliance Insight:
- Don’t argue with or challenge the investigator.
- Do tell the truth. It’s okay to say, “I need to look into that,” but it’s never okay to give false information.
- Don’t offer any more information than what is asked. This just opens opportunities for further investigation.
- Do make sure you understand the question—and seek clarification if you don’t—before you answer.
- Don’t answer a question being asked to a fellow employee.
- Don’t interrupt the investigator or other employees who are talking.
- Do remain aware of your body language, which the investigator may read and interpret.
- Do stick to the facts and refrain from stating your opinions. Avoid phrases such as, “I think.”
- Don’t say things such as, “Off the record,” and “I probably shouldn’t say this, but…”
- Do act confident, but not defiant.
Equip Your Team With Food Safety Training
If you work in the food industry, you need to know food safety basics, the inspection process, common problems areas, and special considerations for foreign facilities. Bazigos tackles all these issues and more in her live audio boot camp. You’ll come away equipped, not only to prepare for an inspection, but also to handle any citations issued—and to prevent future tickets from being written.
