Transcription of FDA Inspection Manual
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FDA Inspection Manual
1. FDA Inspection Manual A PRACTICAL GUIDE. by Richard E. Gutting, Jr. Sponsored by Seafood Products Association 1600 South Jackson Street Seattle, WA 98144. 206-323-3540. 2. This Manual is an educational guide for owners, managers and quality control directors of seafood facilities processing ready-to-eat products when their facility is inspected by the food and Drug Administration and they must respond to alleged violations. It does not constitute legal advice. Recommended actions are not intended to cover every situation and may not apply to your situation. Readers should consult with their legal and technical advisers to ensure that their procedures meet relevant requirements. About the Author Richard E. Gutting Jr. is a partner with the law firm of Redmon, Peyton & Braswell LLP.
4 Introduction In 2011 the Food Safety Modernization Act (FSMA)1 directed the U.S. Food and Drug Administration (FDA) to increase its inspections of foreign and domestic food facilities and to
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