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Winter/Spring 2008

• Update (July 21, 2008) in Compliance References the Regulatory Procedures Manual (RPM), Chapter 4, Ex. 4-1 has been revised, details on the revisions and update page.
• Update (July 17, 2008) in Compliance Reference, BIMO Restricted List for Clinical Investigators
• Update (July 3, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (June 23, 2008) in Compliance References the Regulatory Procedures Manual (RPM) , Chapter 4 has been revised, details on the revisions and update page.
  
• Update (June 2, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (May 15, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (May 06, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (April 30, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators (Achreja)
• New (April 25, 2008) in Compliance Reference, Compliance Policy Guide (CPG) "Guidance for FDA Staff, Section 500.500, Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces."
• New (April 24, 2008) Federal, State and Local Partners "50 State Meeting" event pages.
• Update (April 18, 2008) in Compliance Reference, BIMO Restricted List for Clinical Investigators
• Revision of the 1998 Guide to Inspections of Acidified Food Manufacturers primarily to clarify what an acidified food is, and what are excluded foods; and to add additional detail on processing equipment.
• Update (March 21, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (February 25, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (March 05, 2008) in Compliance References the Regulatory Procedures Manual (RPM) has been revised, details on the revisions and update page
• New (February 27, 2008) in ORA Reading Room: Changzhou SPL Company, Ltd., Changzhou City, Jiangsu, China, 483 Inspectional Observations
• Update (February 25, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (February 19, 2008) in Compliance References the Regulatory Procedures Manual (RPM) Chapter 9 has been revised, details on the revisions and update page.
• Update (February 14, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• Update (February 11, 2008) in Compliance Reference, BIMO Disqualified/Totally Restricted List for Clinical Investigators
• New (February 07, 2008) in Inspection Reference: published the 2008 Edition of the Investigations Operations Manual (IOM)
• New (February 07, 2008) in ORA Reading Room: United States v. American National Red Cross, Civil Action No. 93-0949 (JGP)
• New (February 07, 2008) in Compliance Reference: draft containing Nonbinding Recommendations - Not for Implementation revised CPG Section 555.320 Listeria monocytogenes DRAFT GUIDANCE.
• New (January 9, 2008) in Compliance Reference: draft of revised CPG Section 575.100 Pesticide Chemical Residues in Food - Enforcement Criteria.

Fall 2007:

• Updated (December, 2007) ORA Laboratory Manual, version 1.5 is now available online.
• New and removed (November 8, 2007) in Compliance Reference: new Medical Device Program supersedes three other programs, now withdrawn.
• Update (September 28, 2007) in Compliance References of the Regulatory Procedures Manual (RPM) has been revised:
  • Chapters 4 (Advisory Actions), 5 (Administrative Actions), and 6 (Judicial Actions) were revised to remove references to HFA-224.
  • Chapter 4 was further revised as follows:
    • Section 4-1-4 Center Concurrence and Letters Issued By Centers, Paragraph 5 Center for Veterinary Medicine (CVM), was revised to reflect the Regulatory/Administrative guidance in Compliance Program 7371.006:
      • Subparagraph b. was revised to read: "b. Tissue residue violations involving meat and poultry where no tolerance has been established, extra-label use is documented, and/or those which involve the use of compounded drugs or other drug adulteration;" and the footnoote in subparagraph b. that had allowed CVM to grant districts direct reference authority on a case-by-case basis was deleted.
      • New subparagraph c. was added to require CVM concurrence for:  "c.  Tissue residue violations involving aquacultured seafood, and other animal-derived products."
      • The remaining subparagraphs c-f were renumbered as d-g.
    • Section 4-1-18 Tracking; 1. Identification of Warning Letters was revised  to reference the use of the Compliance Management System (CMS) for Tracking Warning Letters.
    • New Section 4-2-2 Tracking; 1. Identification of Untitled Letters was added to reference the use of the CMS for tracking Untitled Letters.
• Update (September 5, 2007) in Compliance Reference: revised entries for William K. Summers, MD, CA, in Restricted List for Clinical Investigators and Removed List for Clinical Investigators.

Summer 2007:

• Update (August 30, 2007) in Compliance Reference: revised Disqualified/Totally Restricted List for Clinical Investigators to add Sheldon R Bender, MD, Philadelphia, PA.
• Update (August 8, 2007) in Compliance Reference: revised Restricted List for Clinical Investigators to remove Walter N Gaman, M.D. Irving, TX, and add to Removed List for Clinical Investigators.
• Update (August 1, 2007) in ORAU Training "Basics of Auditing for Regulators"
• New (July 13, 2007) in ORA Reading Room: Shelhigh, Inc., Union, New Jersey - June 22, 2007, Consent Order
  

Winter/Spring 2007:

• New (May 4, 2007) in ORA Reading Room: Shelhigh, Inc., Union, New Jersey - May 2, 2007, FDA Requested Recall
• Update (May 2, 2007) in Inspection Reference:
  updated the ORA Directory pages of the Investigations Operations Manual (IOM) and Chapter 1, Section 2 Travel.
• New (May 1, 2007) in ORA Reading Room: Shelhigh, Inc., Union, New Jersey - April 16, 2007, Complaint for Forfeiture
• New (April 30, 2007) in ORA Reading Room updated for Shelhigh Inc., Complaint for forfeiture.
• Update (April 27, 2007) in Compliance References, within the Regulatory Procedures Manual March 2007, updated Chapter 4 (Advisory Actions) and the Revisions page.
• New/Update (April 26, 2007) in ORAU: updated Training Curriculum for State, Local & Tribal Regulators Retail Food Curriculum to reflect the following new pages:
  • Performance Audit
  • Audit Criteria
  • Audit Failure Reference Guide
  • Guide to the Performance Audit Process
  • Audit Worksheet Form ( PDF 10 kb; Word , 37 kb)
  • Audit Results Summary form ( PDF 58 kb; Word , 36 kb)
  • Auditor Feedback Form ( PDF 60 kb; Word , 36 kb)
    
• New/Update (April 19, 2007) in Federal-State Relations: published "Appendix A: Model (Standard) Medical Gas Partnership Agreement" (HTML) and ( PDF, 43KB)
• New (April 17, 2007) in ORA Reading Room: American National Red Cross/Biomedical Services, Washington, D.C., April 4, 2007 Adverse Determination Letter
• Update (April 16, 2007) in Compliance References: updated Debarment List and Revisions.
• Update (April 11, 2007) in Compliance References: updated BIMO (Bioresearch Monitoring Program Coordination Background) Guidance for Industry Good Laboratory Practice Regulations Management Briefings Post Conference Report, dated August 1979, and AIP Contacts.
• New (March 28, 2007) in Compliance References: published the 2007 Edition of FDA Regulatory Procedures Manual.
• New (March 22, 2007) in About the Office of Regulatory Affairs: added The Enforcement Story 2006
• New (March 07, 2007) in About the Office of Regulatory Affairs: added the new ORA Quality Manual and published an updated Vision, Mission, and Quality Commitment statement for ORA.
• Update (February 23, 2007) in Federal_State Relations: Small Business Regional Contacts lists.
• New (February 23, 2007) In Training, added link to ALERT Food Defense Awareness on web based training courses.
• New (February 8, 2007) in Inspection Reference:
  published the 2007 Edition of the Investigations Operations Manual (IOM)
• Update (February 6, 2007) Inspection Reference, revised Field Management Directives, table of contents format for consolidation of separate indices into a single table with user selectable sorting by selection of column titles.
• Update (January 8, 2007) in Federal State Relations: change in contact information for requests to update the State Directory Table pages.
• New (January 4, 2007) in Federal State Relations: Link for 30-day Federal Register Notice for Submitting the MFRPS for Review by OMB. COMMENT PERIOD ENDS January 17, 2007.

Fall 2006:

• New (December 7, 2006) - American Red Cross/Biomedical Services, Washington, D.C., Consent Decree Correspondence, dated 11/15/2006 (regarding Adverse Determination Letter, paragraph X, dated 09/17/2006 ), in ORA Reading Room.
• New (November 21, 2006) - American Red Cross/Biomedical Services, Washington, D.C., NYPR Adverse Determination Letter, dated 09/07/2006 in ORA Reading Room.
• Updated (November 21, 2006) Federal-State Relations Small Business Guide Small Business Representatives and Regional Small Business Representatives
• New (September 11, 2006) - American Red Cross/Biomedical Services, Washington, D.C., Adverse Determination Letter, dated 09/07/2006 in ORA Reading Room.

Summer 2006:

• Update (August 25, 2006) in Compliance Policy Guides, Chapter 1, new link to (CFSAN) 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
• New (August 23, 2006) in ORA Electronic Reading Room copy of "United States of America vs. Utah Medical Products, Inc.", October, 2005 posted with associated Inspectional Observations and Establishment Inspection Reports.
• Update (August 21, 2006) in Federal State Relations: updated Public Affairs Specialists pages: Public Affairs Specialists and Regional Locations pages
• Update (August 4, 2006) in Compliance Reference: Revised list to change comment for Dr Wholey, Restricted List for Clinical Investigators
• New (August 1, 2006) - American Red Cross/Biomedical Services, Washington, D.C., Adverse Determination Letter, dated 07/27/2006 in ORA Reading Room.
• New (July 3, 2006) - Sanofi Pasteur, Inc., 483 Inspectional Observations, Swiftwater, PA, dated 04/18/2006 - 04/28/2006 in ORA Reading Room.

Winter/Spring 2006:

• Update (June 28, 2006) in Inspection Reference:
  the Inspection Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations has been updated to make reference to the recently published Guide to Produce Farm Investigations.
• Update (June 19, 2006) in Compliance Reference the March 2006 Edition of the Regulatory Procedures Manual (RPM) has been published. All chapters with the exception of Chapter 9 were updated and published as PDF files.
• Update (June 2, 2006) in Inspection Reference:
  updated the ORA Directory pages of the Investigations Operations Manual (IOM)
• Update (May 26, 2006) in Compliance Reference: Revised list to add 1 new member, Restricted List for Clinical Investigators
  Update Revisions page for link to new CFSAN Draft Policy Guide for 3-MCPD
• New (May 23, 2006) Disaster Evacuation Card page: information relating to the Disaster Evacuation Card to be used by ORA personnel in the event of national or local disaster.
• New (May 16, 2006) Bausch & Lomb, 483 Inspectional Observations, Greenville, SC, dated 03/22/2006 - 05/15/2006 in ORA Reading Room
• Update (May 16, 2006) in Compliance Reference Recalls to page Medical Device Model Press Release.
• Update (May 3, 2006) in ORAU's State Training Team Schedule for postponement of FD104 in Providence, RI, on 6/27-29, 2006.
• New (May 1, 2006) in ORA Electronic Reading Room, FDA 483 Inspectional Observation for Andrx Pharmaceutical, Inc., inspection in March - April 2006.
• Update (April 25, 2006) in Compliance References, revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990
• New (April 18, 2006) in ORAU's Broadcast and Videoconference Announcements Page, published Food Defense Terms and Acronym List
• New (April 4, 2006) in ORA Electronic Reading Room, FDA 483 Inspectional Observations and Establishment Inspection Reports regarding four Utah Medical, Inc. inspections in 2001 through 2004.
  
• Update (April 4, 2006), the ORA "Frequently Requested FOI Reading Room" page is renamed to "ORA Electronic Reading Room" to better reflect the content.
• Update (March 30, 2006) in ORA U Training posted updated course curricula of the FDA’s draft Voluntary National Retail Food Regulatory Program Standards:
  • Training Curriculum for State, Local & Tribal Regulators Retail Food Curriculum
  • Training Curriculum for State, Local & Tribal Regulators Milk Curriculum
  • Training Curriculum for State, Local & Tribal Regulators Shellfish Curriculum
  • Training Curriculum for State, Local & Tribal Regulators Manufactured Foods Curriculum
  • Training Curriculum for State, Local & Tribal Regulators Feed Control Curriculum
  • ORA U Level 1 Curriculum
• New (March 10, 2006) in Inspection Reference:
  published the 2006 Centennial Edition of the Investigations Operations Manual (IOM)
• Update (March 8, 2006) in Compliance Reference: Revised list to add 1 new member, Restricted List for Clinical Investigators, along with the Revisions page
• Update (March 6, 2006) in Training/ORAU:
  • Broadcast and Videoconference Announcements: "Food Defense Awareness" on March 29, 2006, closed captioned
  • "Food Defense Awareness (FD171)"
  • Sign In Sheet (PDF Size 14 kb)
  • Participant Form (PDF Size 14 kb)
• Update (March 2, 2006) in Federal-State Relations
  • Up and Coming Events: Conference Announcement: "FDA Clinical Trials Requirements Regulations, Compliance and Good Clinical Practice" on May 17-18, 2006, in Baltimore, MD.
  • Past Meetings
  • Federal-State Relations Start Page
• Update (February 24, 2006) in Federal-State Relations, 29 files in Directory of State and Local Officials:
  • Alaska
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Maine
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Mexico
  • New York
  • North Carolina
  • Ohio
  • Oklahoma
  • Oregon
  • Texas
  • Virginia
  • Washington
  • Wisconsin
• Update (February 23, 2006) in Compliance Reference of the Regulatory Procedures Manual (RPM) has been revised:
  • Chapter 2, (FDA Authority), of the Regulatory Procedures Manual has been revised to:
    • include summaries of the following laws:
      • Food Allergen Labeling and Consumer Protection Act of 2004;
      • Minor Use and Minor Species Animal Health Act of 2004;
      • Project BioShield Act of 2004; and
      • Pediatric Research Equity Act of 2003
    • update the penalties in 18 U.S.C. Sections 111, 1341, and 1343, and the persons covered by 18 U.S.C. 1905; and,
    • reformat and restructure content to improve clarity and consistency.
  • Chapter 7, (Recall Procedures), of the Regulatory Procedures Manual has been revised to:
    • change Subsection 7-5-1 Firm Initiated Recalls, heading "Establishment Inspection" to state that, in the case of class I or significant class II recall situations, an establishment inspection should be conducted to determine the root causes of the problem and document violations for possible regulatory action if appropriate corrective action is not being implemented, and evaluate overall compliance;
    • update Subsection 7-5-3 FDA Ordered Recalls, heading "Mandatory Recall of Human Tissue for Transplantation" to reflect the new tissue regulations;
    • remove obsolete Attachment H - "Mandatory Recalls of Human Tissue for Transplantation";
    • rename "old" Attachment I, as Attachment H; and,
    • reformat and restructure content to improve clarity and consistency.
  • Update/New (February 17, 2006) in ORAU: updated State Training Team Courses and Training Materials, and published new page, State Training (STT) FY06 Classroom Schedule and Registration Contacts
  • Removed (February 15, 2006) from Inspection Reference: in Field Management Directives removed content for FMD 130 and 5 attachments "Establishment Inventory (OEI) Development and Maintenance Procedures" for review by the issuing office, Division of Planning, Evaluation, and Management. The revised version will be posted once the review is completed.
  • Update (February 10, 2006) in Science Reference: Laboratory Manual (LM) updated Volume IV sections 2, 3, 4, 5, 6, 7, 10, 11, 14.
  • Update February 09, 2006 in Compliance Reference updated the program contact person(s) information on the BIMO pages:
    BIMO Information page
    Bioresearch Monitoring Program Coordination background
    BIMO comparison_chart preface
  • New (February 2, 2006) in Frequently Requested FOI Reading Room, FDA 483 Inspectional Observations regarding six Boston Scientific locations:
    Watertown MA, dated 03/09/2005 - 04/07/2005
    Quincy MA, dated 03/28/2005 - 05/20/2005
    Glens Falls NY, dated 04/12/2005 - 05/06/2005
    (Scimed) Maple Grove MN, dated 07/22/2005 - 08/25/2005
    Natick MA, dated 07/27/2005 - 08/26/2005
    Spencer IN, dated 08/25/2005 - 09/12/2005
    (PDF format)
    For assistance in accessing non-text files, please contact the FDA Office of Enforcement, Patricia Maroney-Benassi, (240) 632-6819.
  • Update (February 2, 2006): in Federal-State Relations, three pages:
    Small Business Representatives
    Central Region, formerly Mid-Atlantic Region
    DFSR Staff Directory
  • New (Jan. 30, 2006) in Frequently Requested FOI Reading Room FDA 483 Inspectional Observations regarding Diamond Pet Food., Gaston, SC: FDA 483 Inspectional Observations, 12/21/2005 - 01/19/2006
    PDF size 110 KB
    For assistance in accessing non-text files, please contact the FDA Office of Enforcement, Patricia Maroney-Benassi, (240) 632-6819.
  • Update (January 27, 2006) in Federal-State Relations: ORA/DFSR Public Affairs Specialists
  • Update (January 23, 2006) in Compliance References:
    Revised Restricted List for Clinical Investigators to remove restriction for 1 member
    Changed classification (Class) for Pine Acres Research Facility, Norton, MA
    Updated Revisions Page
  • Update (January 12, 2006) in Compliance Reference of the Regulatory Procedures Manual (RPM) Chapter 4, Advisory Actions has been revised as follows:
    • These Subsections were modified as follows:
      • 4-1-2, Warning Letters to Government Agencies, was updated generally;
      • 4-1-3, Issuing Warning Letters - Factors to Consider - was revised to address ongoing, promised, and completed corrective actions;
      • 4-1-4, Center Concurrence and Letters Issued by Centers, was revised to add the following to warning letters that require center concurrence: Pharmacy Compounding (CDER); Violative inspections of manufacturers of human cell, tissue, and cellular and tissue-based products (HCT/Ps) (CBER); and Cosmetics (CFSAN);
      • 4-1-6, Multiple Center Review, was changed to describe the designation and responsibilities of a "lead center";
      • 4-1-8, Warning Letter Follow-Up, was expanded to further address the issuance of a second warning letter;
      • 4-1-10, Warning Letter Format, was changed to describe the use of dual cites (i.e., to the Act and U.S. Code) and standard statements in warning letters, and the issuance of copies of warning letters;
      • 4-1-12, Warning and Untitled Letters Addressed to Importers, Customs Brokers, and Foreign Firms, was updated generally;
      • 4-1-13, Freedom of Information (FOI), was updated to provide additional information on handling internet posting and FOI requests for warning letters;
      • 4-1-14, under CBER Program Warning Letters, was updated to remove references to compliance programs and make editorial changes; and,
      • 4-1-15, under Standard CDER Charges, and Sample Wording for (CDRH) Charges, was modified to add 21 U.S.C. cites to the examples.
    • Exhibit 4-1, Procedures for Clearing FDA Warning Letters and Untitled Letters, was updated to delete references to having OCC revise proposed letters to address a FDA-483 response, to revise Sec. 6.4 to further describe district and center responsibilities for letters issued under the audit review program, and to add Seafood HACCP letters to the program.
    • Finally, throughout this chapter content was reformatted and restructured to improve clarity and consistency. As other RPM chapters are updated, they will be converted to this new format and structure, as well.

   

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