Tuesday, March 12, 2013

What Should I Expect During An Inspection? - FDA Basics

FDA Basics for Industry > What should I expect during an inspection?:

"FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions." . . .

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You might also be interested in:
Surviving An FDA Inspection - A live, in-person, onsite, in-plant course

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