FDA Investigations Operations Manual
Author : United States. Food and Drug Administration
Publisher :
Page : 646 pages
File Size : 17,59 MB
Release : 1992
Category : Food adulteration and inspection
ISBN :
Author : United States. Food and Drug Administration
Publisher :
Page : 646 pages
File Size : 17,59 MB
Release : 1992
Category : Food adulteration and inspection
ISBN :
Author : Mindy J. Allport-Settle
Publisher : Pharmalogika
Page : 800 pages
File Size : 30,31 MB
Release : 2010-01-15
Category :
ISBN : 9780982147627
The IOM is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. Adherence to this manual is paramount to assure quality, consistency, and efficiency in field operations. The specific information in this manual is supplemented, not superseded, by other manuals and field guidance documents. The IOM is recommended reading for all operations regulated by the Food and Drug Administration.
Author : United States Food and Drug Administration
Publisher :
Page : 592 pages
File Size : 14,55 MB
Release : 2000
Category :
ISBN :
Author : Food and Drug Administration
Publisher :
Page : 0 pages
File Size : 23,88 MB
Release : 2003
Category : Drugs
ISBN : 9780865879737
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author : United States. Food and Drug Administration. Division of Field Investigations
Publisher :
Page : 541 pages
File Size : 21,51 MB
Release : 1994
Category :
ISBN : 9780914176602
Author : United States. Food and Drug Administration
Publisher :
Page : 603 pages
File Size : 48,98 MB
Release : 2004
Category : Drugs
ISBN : 9781932074222
Author : United States. Food and Drug Administration
Publisher :
Page : 554 pages
File Size : 15,27 MB
Release : 1996
Category : Drugs
ISBN :
Author : United States. Food and Drug Administration
Publisher :
Page : 575 pages
File Size : 30,11 MB
Release : 2001
Category :
ISBN :
Author : United States Food and Drug Administration
Publisher :
Page : pages
File Size : 29,65 MB
Release : 2003
Category :
ISBN : 9781932074147
Author :
Publisher :
Page : 459 pages
File Size : 25,1 MB
Release : 2002
Category : Drugs
ISBN :