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Violations of 21 Cfr Part 803 - Medical Device Reporting: Warning Letters Issued by U.S. Food and Drug Administration by C Chang (Paperback / softback, 2015)

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About this product

Product Information

Inspection teams often kw that a deficiency at one company will often be found at others, so they tend to look for what teams have found in previous inspections. A numerical analysis of past inspections results in the discovery of inspection trends for future inspections. This analysis contains a collection of violations listed in the Warning Letters (WLs) issued by U.S. Food and Drug Administration (FDA) that are available to the public on FDA website, www.fda.gov, as of May 23, 2015. Specifically, the violations included in this analysis are extracted from Warning Letters issued since January 2005. The violations collected here are specifically for failures to meet the requirements described in U.S. Code of Federal Regulations (CFR) Title 21 Food and Drugs, Part 803 Medical Device Reporting. As of May 23, 2015, there were 542 warning letters issued describing violations of Code of Federal Regulations Title 21 - Food and Drugs Part 803 Medical Device Reporting. Within these warning letters, 776 violations are listed in this book. The analysis also includes summary of FDA Inspectional Observation issued on Form 483.

Product Identifiers

Publisher
Createspace Independent Publishing Platform
ISBN-10
1514627094
ISBN-13
9781514627099
eBay Product ID (ePID)
216743163

Product Key Features

Author
C Chang
Format
Paperback / Softback, Trade Paperback (US) ,Unsewn / Adhesive Bound
Language
English
Subject
National Law: Professional
Type
Textbook

Additional Product Features

Content Note
Black & White Illustrations
Date of Publication
09/07/2015
Country of Publication
United States

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