Cramer’s Corner – Chapter 2, Slide 1

October 1st, 2022 by Jim Miller

FDA Inspections

Per Michael Cramer, “It’s a beautiful, sunny day outside and the plant is running well. You’re sitting in your office or in a meeting with your FSQA team, when you get a call from the receptionist informing you that there is a FDA inspector at the front and wants to conduct an audit of the facility. What do you do, what are their rights to inspect and how should you go about the inspection? Are you calm or are little beads of sweat forming on your brow??

It can be a little intimidating the first time this happens, but the key to a successful audit is to understand FDA’s authority and the scope of their inspection abilities. In the slide this week, entitled FDA Inspections, I briefly describe the authority of FDA personnel and the means by which you can prepare for their audit to assure that it’s handled in an effective and professional manner.

Authorities of both FDA and USDA for inspection as well as the control actions they may take regarding ingredients, product and facilities are discussed in Chapter 2 of the book, Food Plant Sanitation: Design, Maintenance and Good Manufacturing Practices. Chapter 2 is entitled “Regulatory Inspections and Control Action” and can help you navigate inspections or provide responses to regulatory reports of findings.”

Slide Content
FDA has legal authority to audit/inspect food facilities on a routine or directed basis
– This includes facilities where foods are manufactured, processed, packaged or warehoused.
Access can be expected during reasonable hours when the plant is staffed and operating (handling ingredients or food)
FDA personnel should be expected to produce credentials and may present Form 482, Notice of Inspection.
Plants should have a procedure to:
– Accommodate the FDA personnel and their requests for inspection or document review
– Accompany FDA personnel, take duplicate pictures, collect duplicate samples, take notes
Upon completion, and depending on the findings, the auditor may issue Form 483 that will outline any conditions that require corrections
– Always review the document before signing, consider legal review if needed
– If items found during the audit were corrected, request the inspector note in the 483
– Always provide a detailed and timely response showing correction of each item on the Form 483

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