FDA Warning Letters: Medical Device GMP Breakdown and Analysis: Volume 1: Corrective and Preventive Action

 
9780615435893: FDA Warning Letters: Medical Device GMP Breakdown and Analysis: Volume 1: Corrective and Preventive Action

This book is a collection of FDA (Food and Drug Administration) Warning Letters that were issued from 2003 to 2010. 3154 Warning Letters were sampled and 566 letters contain references to CFR (Code of Federal Regulations) Part 820, 803 and 806. The violations in the warning letters are categorized by the referenced CFR sections and specifications. Volume 1: Corrective and Preventive Action - A collection of violations referenced CFR 820.100 Volume 2: Design Controls - A collection of violations referenced CFR 820.30 Volume 3: Complaint Files - A collection of violations referenced CFR 820.198 Volume 4: Management Responsibility; Quality Audit; Personnel; Definitions; Quality System; Scope - A collection of violations referenced CFR 820.20, 820.22, 820.25, 820.3, 820.5, and 820.1 Volume 5: Receiving, In-Process, and Finished Device Acceptance; Purchasing Controls; Nonconforming Product; Identification; Acceptance Status; Traceability; Reports Of Corrections and Removals - A collection of violations referenced CFR 820.80, 820.50, 820.90, 820.60, 820.86, 820.65, and CFR 806 Volume 6: Production and Process Controls; Process Validation; Inspection, Measuring, and Test Equipment - A collection of violations referenced CFR 820.70, 820.75, and 820.72 Volume 7: Device History Record; Document Controls; Device Master Record; Statistical Techniques; Device Labeling; Servicing; Distribution; Storage; General Requirements; Handling; Installation; Quality System Record; Device Packaging - A collection of violations referenced CFR 820.184, 820.40, 820.181, 820.250, 820.120, 820.200, 820.160, 820.150, 820.180, 820.140, 820.170, 820.186, and 820.130 Volume 8: Medical Device Reporting - A collection of violations referenced CFR 803

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