Regulatory Readiness Assessment

Will You Pass Your Next FDA Inspection?

During this mock FDA inspection, you’ll better understand what FDA investigators are looking for. If you’re unsure whether your plant will pass its next FDA inspection, here are a few questions you should ask:

• Is our regulatory policy in line with 21 CFR Part 117 and 21 CFR 121 IA?
• Do our employees understand our plant’s policy for handling regulatory inspections and are they following it?
• Are our employees executing our food safety plan and intentional adulteration/food defense plan the way it is written?
• Is our regulatory inspection team prepared to answer all questions posed by the FDA investigator?

Let us evaluate your facility’s reaction to an on-site FDA audit/visit. This is an excellent learning experience for any FDA-registered food facility (manufacturer, warehouse, or distribution center) in the United States, as well as those exporting to the U.S.

Please note the Regulatory Readiness Assessment may be customized to site-specific needs.

How the Process Works

The Regulatory Readiness Assessment is a role-play exercise where an AIB International food safety professional asks questions as the FDA investigator.

Our food safety professional enters the plant at reception and explains he or she is role-playing as an FDA investigator.

1. Evaluation of site personnel responses starts immediately, and we use a moderately assertive demeanor to simulate an actual FDA investigator.
2. Records review: This includes intentional adulteration/food defense plans and food safety plans.
3. Interviews: We interview your regulatory team members and employees on the floor.
4. Inspection: Processing and packing areas are inspected and findings are documented.
5. Assessment: This provides the opportunity to challenge and prepare your regulatory team’s responses to an FDA investigator’s questions during a routine FDA visit. Challenges may include taking photos, collecting samples, and collecting labels.
6. Report: We detail responses and highlight issues that would be reported on an FDA Form 483.