Fall, 2005
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Summer, 2005
- Update: (August 9, 2005) in Import:
Added link to Import start page for information on CFSAN pages for Cosmetics Importers
to address confusion regarding voluntary registration for the importation of cosmetics.
- New: (July 29, 2005) in Inspection
Reference: in Guides to Inspections
added Guide to Inspection of Aseptic
Processing and Packaging for the Food Industry, published in February 2001 and now
available on the web.
- Update: (July 26, 2005) in Compliance Reference CPG pages updated CPG Sec. 315.100 "Illegal
Interstate Commercial Shipment of Dentures (CPG 7124.07)" and updates to Revisions, CPG TOC and CPG Devices TOC pages.) (7-28-2005
Editorial changes to section wording and dates/numbers in Background sub section.)
- Update: (July 22, 2005) in Federal State Relations Activities
updated the Aids
Health Fraud Task Force page.
- New: (July 22, 2005) in Inspection Reference: in Field Management Directives added FMD 151, Compliance Review & District
Conclusion for BSE Samples
- Update: (July 13, 2005) in Science Ref:
updated PDF sections of the Laboratory Manual:
Vol 1 (all), Volume II, Section 5.5, Volume III, Sections 6 and 7
- New: (July 13, 2005) in Frequently Requested
ORA Documents and FDA 483s: American National Red Cross/Biomedical Services,
Washington, D.C., Modified Adverse Determination Letter [HTML] PDF (size 899 KB) Attachment [HTML]
and link to Able Laboratories, Inc., Cranberry,
NJ, FDA 483 Inspectional Observations, dated 05/02-07/01/2005
- Correction: (June 30, 2005) in This
page (Whatsnew): corrected links for June 10 entries for Evans-Chiron FDA 483
Inspectional Observations PDF files.
- Update: (June 21, 2005) in Compliance
Reference: updates to the Regulatory Procedures
Manual:
- Update: (June 16, 2005) in Compliance
Reference: editorial change to remove out of date position names and update contact
information in the CPG Forward
- New: (June 10, 2005) in Frequently
Requested FOI Reading Room HTML versions of previously posted PDF (EIR and 483s)
regarding Evans Vaccine, Ltd., affiliate of Chiron Corp., Liverpool, UK:
- Correction: (June 8, 2005) in Compliance
Reference: Restricted list for Clinical Investigators remove duplicate entry for Briggs
- Update: (June 1, 2005) in Compliance
Reference: Restricted list for Clinical Investigators add 1 Todd V. Swanson
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Winter/Spring, 2005
- New: (May 23, 2005) in Federal
State Relations Electronic State Access to FACTS published the ESAF V1.1 Release Notes.
- New: (May 19, 2005) in Frequently Requested
ORA Documents and FDA 483s: American National Red Cross/Biomedical Services,
Washington, D.C., May 16, 2005
Adverse Determination Letter (HTML) PDF (36KB) and Attachment(HTML) PDF (282KB)
- Update: (May 13, 2005) in CPGM:
minor editorial changes, updated redirect links for 42_006.PDF and 45_001.PDF superceded
by 7345.848 "Inspection of Biological Drug Products" linked from CBER page http://www.fda.gov/cber/cpg/cpg.htm
- New: (April 29, 2005) in Inspection
Reference: in Field Management Directives added FMD 150 Review of Human Subject Research
- Update: (April 25, 2005) in Compliance
Reference: Restricted list for Clinical Investigators (add 3) Batshaw; Raper; Wilson
- Update: (April 20, 2005) in Compliance Reference CPG pages updated CPG Sec. 300.500
"Reprocessing of Single Use Devices (CPG 7124.16) ” formerly "Reuse of
Medical Disposable Devices " (changes in name to Revisions, CPG TOC and CPG Devices TOC pages.)
- New: (April 8, 2005) in Frequently
Requested ORA Documents and FDA 483s: American National Red Cross/Biomedical Services,
Washington, D.C., March 28, 2005, Adverse Determination Letter [html], PDF 114KB
- Update: (April 1, 2005) in Science
Reference updated two volumes of the Laboratory
Manual 2004 (LM) replacing:
- Volume II, Section 5.4.6
Procedure, ORA-LAB.5.4.6, revised to be in accordance with the A2LA policy on Measurement
Uncertainty and the Life Sciences Annex issued 02/08/05. The annex lists only three
measurement uncertainty categories: Qualitative, Well-recognized Methods, and Other.
- Volume III, Section 3
Procedure: Vol III, Section 3, 3.7 Title - 704 (d) removed. This section did not address
704(d) letters. This topic is addressed in ORA-LAB. 5.10, Section H. 3.
- Correction: (Mar 29, 2005) in Training/ORAU
minor correction to the Food Security Awareness
Course to remove reference to "Coop milk inspectors".
- Updated: (March 22, 2005) in Compliance
Reference updated Chapter 4 of the Regulatory Procedures Manual.
- New: (March 7, 2005) in Inspection
Reference published the Investigations
Operations Manual (IOM) 2005 Edition.
- Update: (March 3, 2005) in Compliance
Reference updated 3 pages for PN Revised CPG Sec. 110.310 Prior Notice of Imported
Food...rev5 March 2005:
- Update: (March 2, 2005) in Federal
State Relations updated the Events page
for the Public Workshop "FDA Drug Education Forum" on May 11, 2005.
- Update: (Feb 23, 2005) in Compliance
Reference updated 4 chapters (PDF) of the Regulatory Procedures Manual.
- New: (Feb 22, 2005) in Training/ORAU
published the Food Security Awareness Course.
- New: (Feb 18, 2005) in Compliance
Reference posted draft guidance Sec. 310.210 Blood Pressure
Measurement Devices (Sphygmomanometers) - Accuracy (CPG 7124.23).
- Refreshed: (Feb 14, 2005) in About ORA
refreshed the ORA Overview pages. (Content in
revision, only updated page layout.)
- Refreshed: (Feb 14, 2005) in Guides to Inspections: Foods updated
navigation in TOC pages to provide cross links to Parts 1, 2, and 3. (No change to content, only updated
page links.)
- New: (Jan 19, 2005) in Federal
State Relations published the ESAF FAQ.
- Update: (Jan 7, 2005) in Federal
State Relations published the Calendar of State Meetings FY2005.
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