Inspections, Compliance, Enforcement, and Criminal Investigations
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2006 Revisions and Updates
- 11/21/2006:
Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated November 21, 2006 - 11/09/2006:
Compliance Program Guidance Manual, Program 7342.007 "Examination of Blood and Blood Components Offered for Import" is withdrawn and replaced by Program 7342.007 "Imported Human Cells, Tissues, and Cellular and Tissue-based Products". The withdrawn Program was never electronically available but the replacement Program is now on-line. - 11/02/2006:
CPG Manual Revised; "Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)", updated generally, and specifically with respect to device registration regulations. - 10/23/2006:
Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators - 10/17/2006:
Revised Debarment List, 10/17/2006 - One person added. - 10/11/2006:
Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators - 08/24/2006:
New Guidance That Replaces CPG Sec 110-300, Compliance Policy Guide Guidance for FDA Staff Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 - 07/07/2006: Compliance Policy Guide Sec. 608.100 Human-Labeled Drugs Distributed and Used in Animal Medicine is obsolete and was withdrawn July 7, 2006. See 71 FR 38650, Jul. 7, 2006.
- 07/07/2006: Compliance Policy Guide Sec. 616.100 Streptomycin Residues in Cattle Tissues is obsolete and was withdrawn July 7, 2006. See 71 FR 38650, Jul. 7, 2006. This CPG was superceded by 21 CFR 556.200.
- 06/20/2006:
Compliance Program Guidance Manual: Program 7371.001, "Animal Drug Manufacturing Inspections" revised; program formerly titled "Drug Process and New Animal Drug Inspections." - 08/04/2006:
Clinical Investigator Agrees to Restrictions. See Restricted List for Clinical Investigators for the details. - 07/26/2006:
Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated July 26, 2006 - 07/17/2006
Revised list to add 1 new member, Restricted List for Clinical Investigators - 06/20/2006
New Guidance which Replaces CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (CPG 7132c.02) - 06/20/2006
DRAFT COMPLIANCE POLICY GUIDE 160.900 Prescription Drug Marketing Act – Pedigree Requirements under 21 CFR Part 203 - 06/19/2006
March 2006 edition of the Regulatory Procedures Manual (RPM) published. - 06/15/2006:
Compliance Program Guidance Manual: Program 7382.845, "Inspection of Medical Device Manufacturers " revised. - 05/26/2006:
Draft Compliance Policy Guide:
Guidance Levels for 3-MCPD (3- chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces
Revised list to add 1 new member, Restricted List for Clinical Investigators - 05/16/2006:
Revised Medical Device Model Press Release - 05/09/2006:
Revised list to change status to Active - Exygen Research, State College, PA - 04/07/2006:
Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated April 7, 2006 - 03/08/2006:
Revised list to add 1 new member, Restricted List for Clinical Investigators - 02/09/2006:
Updated the program contact person (s) information on the following pages:
http://www.fda.gov/ora/compliance_ref/bimo/default.htm
http://www.fda.gov/ora/compliance_ref/bimo/background.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html - 01/19/2006:
Change in classification (Class) - Pine Acres Research Facility, Norton, MA - 01/11/2006:
Updated list to remove restriction for 1 member. Restricted List for Clinical Investigators
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