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What is an FDA Form 482?

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.

What are 5 things the FDA is responsible for?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.

What does the FDA check for?

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nations food supply, cosmetics, and products that emit radiation.

What does the FDA investigate?

FDA Inspections The FDA takes its responsibility seriously to ensure the foods we eat are safe and the medical products we use and rely on meet our rigorous standards for quality, safety and effectiveness. The agency uses risk-based approaches to identify foreign and domestic facilities for inspection.

What is the full form of IOM in pharma?

The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators and other field employees to perform investigational activities in support of the agencys public health mission.

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