Form 482 procedure 2025

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FDA Form 482 - Notice of Inspection: It is an official notice of FDA for inspection signed by the FDA officials. It is produced by the inspector and has the authority to inspect the manufacturing facility. Inspection coordinator will receive the notice and manage the inspection ingly.
At all times, escort the inspector or designee during the inspection and review of documents. Inform the entire site that the inspection is in progress. The inspection readiness team should begin the audit support room setup plan.
A Form FDA 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic (FDC) Act and other Acts or regulations.
Before an inspection ask the inspector to provide the Form 482 Notice of Inspection if they do not present it or if the inspector declines to provide the notice in writing, the inspection may be part of a criminal investigation and require a search warrant.
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.
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