Current
Winter/Spring
2008
- Update (March 11, 2009) in Compliance References the Regulatory
Procedures Manual (RPM), details on the revisions and update page.
- Update (January 29, 2009) in Compliance References the Regulatory
Procedures Manual (RPM), Chapter 5, has been revised, details on the revisions and update page.
- Update (November 10, 2008) in Compliance Reference, BIMO Disqualified/Totally
Restricted List for Clinical Investigators
- Update (October 24, 2008) in Compliance Reference, BIMO Disqualified/Totally
Restricted List for Clinical Investigators
- Update (September 29, 2008) in Compliance References the Regulatory
Procedures Manual (RPM), Chapter 10, has been revised, details on the revisions and update page.
- Update (September 9, 2008) in Compliance Reference, BIMO Disqualified/Totally
Restricted List for Clinical Investigators
- Update (September 2, 2008) in Compliance Reference,
BIMO Disqualified/Totally
Restricted List for Clinical Investigators
- Update (August 22, 2008) in Compliance Reference,
BIMO Disqualified/Totally
Restricted List for Clinical Investigators
- Update (August 6, 2008) in Compliance Reference, BIMO
Disqualified/Totally
Restricted List for Clinical Investigators
- 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:
- 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:
- 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:
- Update (March 2, 2006)
in Federal-State
Relations
- 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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