Cantitate/Preț
Produs

Violations of 21 Cfr Part 820 Quality System Regulation, Subparts H-I

Autor C. Chang
en Limba Engleză Paperback
Inspection teams often know 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 820 Quality System Regulation Subparts H-I, Acceptance Activities and Nonconforming Product. As of May 23, 2015, there were 609 warning letters issued describing violations of Code of Federal Regulations Title 21 - Food and Drugs, Part 820 Quality System Regulation Subparts H-I, Acceptance Activities and Nonconforming Product. Within these warning letters, 891 violations are listed in this book. The analysis also includes summary of FDA Inspectional Observation issued on Form 483.
Citește tot Restrânge

Preț: 74402 lei

Preț vechi: 96626 lei
-23% Nou

Puncte Express: 1116

Preț estimativ în valută:
14246 14696$ 11807£

Carte disponibilă

Livrare economică 30 ianuarie-13 februarie

Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9781514629871
ISBN-10: 1514629879
Pagini: 312
Dimensiuni: 216 x 279 x 17 mm
Greutate: 0.73 kg
Editura: CREATESPACE