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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. and has been actively involved in the regulation of seafood in the United States for over thirty years.

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Transcription of FDA Inspection Manual

1 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. and has been actively involved in the regulation of seafood in the United States for over thirty years.

2 He is the past President of the National Fisheries Institute and has served on several governmental advisory committees regarding international trade and seafood. Prior to joining the NFI in 1982, he served as General Counsel for Fisheries of the National Oceanic and Atmospheric Administration, counsel for the Subcommittee on Fisheries and Wildlife Conservation of the House of Representatives, and as senior legal advisor to the President's Council on Environmental Quality. Prior to his government service, he practiced law as a specialist in oceans, environmental, and resources law. He received his law degree from Stanford Law School and has published many articles and books concerning seafood. Acknowledgment The author and sponsor wish to acknowledge with sincere appreciation the assistance of the experts who generously contributed their time and efforts in the review of this Manual .

3 Their careful analysis and many constructive recommendations greatly enhanced its value and we are sincerely grateful: Chris Rezendes, Mary Snyder, James Yonker, and Howard Tenen. 3. Contents Introduction .. 4. A. FDA Inspection Authority .. 4. 1. What is Reasonable .. 5. 2. Advanced Notice and 7. 3. NOAA Approved Establishments .. 8. 4. Credentials and Notice of 8. 5. Inspection of Records .. 9. 6. FDA Samples .. 12. 7. Photographs .. 14. 8. Affidavits .. 15. B. Preparing for Inspection .. 16. 1. Appoint a Representative .. 16. 2. Prepare an Inspection Manual .. 16. 3. Conduct Training .. 20. 4. Conduct Exercises .. 20. C. During the Inspection .. 22. 1. Arrival of Inspector .. 22. 2. Initial Meeting .. 22. 3. Escorting the Inspector .. 25. 4. Taking Samples .. 26. 5. Preparing a Record of the Inspection .

4 28. 6. Correcting Deficiencies Noted by the Inspector .. 28. 7. Notice of Inspectional Observations (Form FDA 483) .. 28. 8. Exit Meeting .. 29. D. Post 31. 1. Responding to Inspectional Observations .. 31. 2. Obtain Copies of the Establishment Inspection Report .. 32. 3. Monitor FDA's Classification of the Inspection .. 33. 4. Warning Letters .. 34. E. Possible FDA Enforcement Actions .. 37. 1. Administrative Detention .. 37. 2. Seizures and Injunctions .. 37. 3. Registration Suspensions .. 38. 4. Re-Inspections .. 38. 5. Criminal Prosecution .. 39. 6. Private Enforcement .. 40. 7. FDA Ombudsman .. 40. References .. 41. 4. Introduction In 2011 the Food Safety Modernization Act (FSMA)1 directed the Food and Drug Administration (FDA) to increase its inspections of foreign and domestic food facilities and to base these inspections upon FDA also gained new authority to detain and recall products, suspend a facility's registration and collect fees for re-inspections when its inspectors found violations.

5 As a result, processors of high risk potential seafood --- particularly those cooking or smoking ready-to-eat products, or packing refrigerated products in Reduced Oxygen Packaging --- became the most likely seafood processors to be inspected and have the observations of FDA. inspectors escalate into Warning Letters and FDA This Manual explains how FDA inspections have changed under FSMA, and suggests how high risk potential seafood processors can manage and respond to FDA inspections to avoid costly disruptions. A. FDA Inspection Authority FDA's Office of Regulatory Affairs, which is traditionally called FDA's inspectorate or the field , has 4,300 officials organized into 20 district offices and five regions, with over 225. offices/resident posts or home domiciles. It also operates from12 FDA foreign offices, 5 of which include resident investigators.

6 The authority of these FDA investigators and compliance officers to inspect seafood facilities is set forth in Section 7044 of the Federal Food, Drug and Cosmetic Act (FDCA),5 and covers any establishment in which seafood is manufactured, processed, packed or held for introduction into interstate commerce or after such introduction, and any vehicle used to transport seafood in interstate commerce. The key wording is: .. officers or employees .. upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food .. are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food.

7 And (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein .. Each such Inspection shall be commenced and completed with 1. Public Law 111-353. 2. Selection and prioritization of processors and products for Inspection will be risk based. Seafood Processor Inspection Program Domestic and Foreign Facilities (CP ). 3. FDA listed High-Risk Potential Products in its Import Seafood Products Compliance Program in this descending order of priority: Refrigerated seafood products packed in oxygen limiting packaging or reduced oxygen packaged; Raw (fresh and fresh frozen) molluscan shellfish from uncertified shippers;. Ready-to-eat fish or fishery products; Seafood mixes; Scombrotoxin-forming (histamine-forming).

8 Species; Aquacultured seafood; Ready-to-eat fish or fishery products that have not undergone a heat treatment; Salt-cured, and/or air-dried, un-eviscerated fish; and Acidified and low acid canned foods. 4. 21 USC 374. 5. 21 USC 301 et seq 5. reasonable promptness .. Upon completion of any such Inspection .. and prior to leaving the premises, the officer or employee making the Inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food .. in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

9 If the [inspector]. obtained any sample in the course of the Inspection , upon completion of the Inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained .. and an analysis is made of such sample .. a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.. FDA inspectors, therefore, may inspect seafood facilities but are constrained by statutory requirements to: 1) Be reasonable ;. 2) Show appropriate credentials;. 3) Issue a Notice of Inspection to the owner, operator or agent in charge ;. 4) Issue a receipt for any samples collected; and 5) Issue inspectional observations if violations are found. 1. What is Reasonable FDCA Section 704 requires FDA inspections to be conducted at reasonable times, within reasonable limits, and in a reasonable manner and they must be completed with reasonable promptness.

10 6. This wording was not changed by FSMA. No FDA rule, however, defines these reasonableness standards and their meaning has been litigated only a few times. When they have been challenged, courts have determined reasonableness based on whether FDA met the procedural requirements of Section 704 and have said that reasonableness depends on the facts of each situation, such as the enforcement needs of the agency and whether an unnecessary burden is placed on a firm. a) Timing of Inspections The calendar and clock do not establish what time is reasonable for a FDA Inspection . Instead, what is happening in your facility determines what is reasonable. FDA's past practices and its Compliance Program documents, which instruct FDA personnel on how they should conduct different types of FDA inspections, have defined when it is reasonable to conduct an Inspection of a facility under FDCA Section 704.


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