FDA Establishment Inspections: Pharmaceutical, Biotechnology, Medical Device and Food Manufacturing Concise Reference

Establishment Inspections, Chapter 5 of the FDA's Investigations Operations Manual, details every step FDA inspectors are required to follow when conducting a facility inspection. This text is a comprehensive reference for regulatory inspections and is useful as an introduction to the practical components of the FDA-regulated industries or as a refresher. While the specific regulations and requirements may differ widely between pharmaceutical, biotechnology, medical device, and food manufacturers, the inspection processes and procedures do not.

• | Author: Mindy J. Allport-Settle
• | Publisher: Pharmalogika
• | Publication Date: Jul 06, 2010
• | Number of Pages: 358 pages
• | Binding: Paperback or Softback
• | ISBN-10: 098214766X
• | ISBN-13: 9780982147665