Fall, 2004
- New: (December 15, 2004) in Science
Reference published the Laboratory Manual
2004 (LM) replacing the Laboratory Procedures Manual.
- Withdrawn: (December 15, 2004) in Inspection Reference Inspectors Technical Guide
(ITG) page withdrawn for revision ITG Subject:
"Package-Unit" Italian Flour Mills.
- Update: (November 23, 2004) in Compliance Reference updated Application Integrity Policy Information.
- Update: (November 23, 2004) in Import
Program: updated OASIS start page.
- New: (November 17, 2004) in Frequently
Requested FOI Reading Room
Three PDF documents (EIR and 483s) regarding Evans Vaccine, Ltd., affiliate of Chiron
Corp., Liverpool, UK:
Establishment
Inspection Report (EIR), dated 06/02-10/2003
FDA 483
Inspectional Observations, dated 06/02-10/2003
FDA
483 Inspectional Observations, dated 10/10-15/2004
- New: (November 17, 2004) in Recalls pages New Model Recall Press
Release for Medical Device
- New: (November 16, 2004) in Compliance Reference New CPG Sec. 400.210 -
Radiofrequency Identification
Feasibility Studies and Pilot Programs
- Update: (November 8, 2004) in Compliance Reference updated CPG Sec. 130.400 Use of
Microfiche and/or Microfilm for Method of Records Retention (CPG 7150.13).
- Updates: (November 3, 2004) in Compliance Reference:
- Revisions tracking page added links to
11/03/2004 110.300 Food Facilities Registration updates.
- CPG Update history page updated for
110.300 and 110.310 link changes
- Updated links in CPG Chapter 1,
Import/Export TOC section: Registration of Food Facilities (110.300) and Prior
Notice (110.310) entries
- Editorial correction to table of contents entry in Chapter 5 for "560 -
Imports"
- Update: (November 2, 2004) in Compliance Reference: CPG start page added
links to 11/03/2004 110.300 Food Facilities Registration update.
- Update: (November 2, 2004) in Compliance Reference: Revisions page added
links to 10/29/2004 560.400 Milk/Cream Imports Federal Register and Prior Notice updates.
- Update: (October 1, 2004) in About
ORA: The Enforcement Story, 2003 Edition
- Update: (September 3, 2004) in Compliance Reference:
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Summer, 2004
- Update: (August 24, 2004) in Compliance
Reference:
- Update: (August 20, 2004) in Training,
one page, /computer/eLexnet/default.htm
- Update: (August 17, 2004) in Compliance
Reference:
- Update: (August 4, 2004) in Compliance
Reference:
- New: (August 4, 2004) in Frequently
Requested ORA Documents and FDA 483s: American National Red Cross/Biomedical Services,
Washington, D.C., July 13, 2004 Consent Decree Correspondence, [html], PDF
29KB
- Update: (July 30, 2004) in Inspection
Reference:
- New: (July 21, 2004) in Compliance
Reference: BIMO
- Update: (July 20, 2004) in Inspection
Reference:
- Updated pages in the IOM
- Streamlined reconciliation examination guidance in 530.04
- Line 24, Registration requirement text changed to " NO " - applies to both
domestic and foreign firms for Devices covered by an Investigational Device Exemption
(IDE) in Exhibit 550
- tracked updates on Changes Page
- Update: (July 19, 2004) in Import
Program: one page, Import Program System
Information.
Winter/Spring, 2004
- Update: (May 28, 2004) in Compliance
Reference:
- Update: (May 24, 2004) in Federal
State Relations:
- Update: (May 20, 2004) in Compliance
Reference, an update to Application
Integrity Policy Information.
- Update: (May 17, 2004) in Compliance
Reference, an update to Restricted
List for Clinical Investigators.
- Update: (May 11, 2004) in Federal-State
Relations:
- Update: (May 6, 2004) in Regulatory
Procedures Manual (RPM), March 2004 Edition (all chapters, except Chapter 9, are
revised) in PDF format while HTML versions are being prepared.
- Update: (April 23, 2004) in IOM
2004 Edition updates to pages:
- Update/New: (April 22, 2004) in Frequently Requested EFOIA American National Red
Cross/Biomedical Services, Washington, D.C., April 2, 2004, Adverse Determination Letter:
- Update: (April 22, 2004) Training:
- Update: (April 16, 2004) in Federal
State Relations: Small Business Guide pages
- Update/New: (April 15, 2004) in Inspection Reference:
- Update: (April 9, 2004) in Compliance
Reference:
- Update/New: (March 22, 2004) in Federal-State
Relations:
- Update: (March 22, 2004) in Inspection
Reference:
- Update: (March 22, 2004) Training:
- Update: (March 17, 2004) in Compliance
Reference:
- New: (March 15, 2004) in Frequently
Requested EFOIA American National Red Cross/Biomedical Services, Washington, D.C.,
March 8, 2004, Consent Decree Correspondence [HTML], PDF size 20 KB
- New/Update: (March 12, 2004) in ORAU Web Based Courses:
- New/Refresh: (March 11, 2004) in Inspection
Reference: in the Investigations Operations
Manual (IOM) 2004 Edition added new PDF versions for each chapter, refreshed the HTML
pages to include title, description, and keyword metatags. Added new IOM Search page.
- Update: (March 2, 2004) in Compliance
Reference: the Regulatory
Procedures Manual (RPM) Chapter 7 Headquarters Emergency Procedures telephone contact
number change.
- Update: (March 1, 2004) in Inspection
Reference: the Investigations Operations
Manual (IOM) 2004 Edition
- Update: (February 18, 2004) in Compliance Reference:
- Update: (February 12, 2004) in Federal State Relations, Activities & Staff
Directory section, Regional
Food Specialists
- New: (February 12, 2004) in Frequently
Requested EFOIA American National Red Cross/Biomedical Services, Washington, D.C.,
February 11, 2004, Adverse Determination Letter [HTML], PDF size 191 KB
- Update: (February 11, 2004) in Compliance Reference:
- Refresh/New (February 10, 2004) of Training/ORAU Pages. Refreshed the page layout of
all pages. While most page content was not changed, new pages were added for State, Local and Tribal Regulatory Partners
training.
- Update: (February 9, 2004) in Partnership Agreements:
- Refresh (February 9, 2004) of Science
Reference. Refreshed the page layout of all pages, content was not changed.
- Update: (February 9, 2004) in Compliance
Reference: corrected the link to CPG400.700 on page CPGM Chapter 4 (Human Drugs)
- Update: (January 28, 2004) in Federal
State Relations: Small Business Guide pages
- New/Update (January 21, 2004) in Inspection
Reference updated list of Guides to
Inspections for New Salmonella
Enteritidis Guide to Traceback in Eggs (7/03) with links to PDF and MS Word formats
available.
- Refresh (January 16, 2004) of Compliance
Reference and Import Program. Refreshed the page layout of
all pages, content was not changed.
- Update: (January 15, 2004) in Compliance
Reference:
- Update: (January 15, 2004) in Federal-State
Relations: one file, DFSR_Activities/fdapas.html
- New (January 13, 2004): in Federal-State Relations:
- Updated (January 5, 2004): in Training:
- Update: (January 2, 2004) in Federal-State
Relations:
- Update: (January 28, 2004) in Federal
State Relations: Small Business Guide pages
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