Inspections, Compliance, Enforcement, and Criminal Investigations

2011 Revision and Updates

  • 12/07/2011: Chapter 4 of the Regulatory Procedures Manual (RPM) has been revised and updated, as detailed below.

    Chapter 4 - Advisory Actions

    • 4-1-10 Warning Letter Format, Item 13, - is being revised to reflect the heightened interest in drug shortages and the October 31, 2011 Executive Order from President Obama. Adding a reminder of the availability of FDA resources to prevent or reduce the impact of shortages explicitly in WLs would directly support the early notification step in the Executive Order.
  • 9/7/2011: Chapters 3, 7, 10, and Appendix A of the Regulatory Procedures Manual (RPM) have been revised and updated, as detailed below.

    Chapter 3 - Commissioning and Work Sharing

    • 3-3-3 - Background Investigation, 3-3-6 - Contacting the Candidate - Item f.,and Exhibit 3-8 -Form - Basic Information from Candidate -are eachbeing revised to include United States nationals. The scope of commissioning is being broadenedto include United States nationals. This revision is consistentwith the provisions of the FD&C Act.
    • 3-5-2- Conflict of Interest Considerations Before Commissioning - the lastparagraph was inadvertently missing from the previous Internet version of theRPM.
    • Exhibit 3-6 -Model Letter Offering a Commission to an Agency Head - the word "territory" is being added.
  • Chapter 7 - Recall Procedures
    • 7-8-2 - Managing FDA's Audit Program -revised to incorporate GAO recommendations regarding recalls affecting the school lunch program.
  • Chapter 10 - Other Procedures
    • Updated the following sections with current address, phone or fax information: 10-1-3-Debarment -Notification Responsibilities of FDA Employees -Item 2.b.ii;10-10-6 - Obtaining and Paying for Expert Support - Item 2.c.ii; 10-11-1 - Requests for Testimony - Item 1.a; and 10-11-6 - Congressional Requests - Instructions for ORA Staff.
    • Deleted mail codes on Pages 10-15 and 10-23.
  • Appendix A - RPM Change Request Form - Updated OE/DCP phone number.
  • 8/19/2011: Revised Debarment List - Hung Ta Fan added
  • 8/19/2011: Revised Debarment List - Ray Nathan added
  • 8/08/2011: Revised Debarment List - Andrew K. Choi added
  • 6/24/2011: Revised Debarment List - Timothy J. Rosio added
  • 6/24/2011: Revised Debarment List - Stephen Lee Seldon added
  • 6/24/2011: Revised Debarment List - Adrien E. Aiache added
  • 05/20/2011: Chapters 6 & 10 of the Regulatory Procedures Manual (RPM) have been revised and updated, as detailed below.

    Chapter 6 - Judicial Actions

    • 6-1 Seizure - Streamline process for concurrent review.
    • 6-2 Injunctions - Streamline process for concurrent review.
    • 6-3 Inspection Warrants; 6-3-3 Responsibilities - Updated DCMO address and phone number; clarified that "potential or suspect" adulteration and/or misbranding charges should be identified prior to submitting the action in CMS; and added "Any situation that may result in a refusal or delay of an inspection conducted under a warrant" to the list ofwhat should be included in a memorandum requesting an inspection warrant.
    • Exhibit 6-10 Procedures & Models for Issuing Press Releases - Clarified ORA Executive Operations Staff's role and responsibilities and the procedures in general.
    • Chapter 10 - Other Procedures
    • 10-8 Ad Hoc Committee - Added Seizure/Injunction as separate appeal.
    • 10-9 Appeal Process (DCMO) is unchanged and still available for other types of decisions.
  • 05/17/2011:
  • 03/17/2011: The Regulatory Procedures Manual (RPM) has been revised and updated, as detailed below.
    Chapter 4 - Advisory Actions
    • Exhibit 4-1 Procedures for Clearing FDA Warning Letters and Untitled Letters - Updated to reflect the August 2009 shift in review policy.
  • 03/10/2011: Revised Debarment List - Mark E. Van Wormer added.
  • 03/09/2011: Revised Debarment List - Anastasios Pappas added.
  • 03/09/2011: Revised Debarment List¹ - David E. Berman added.
  • 03/03/2011: Revised Debarment List - Albert Poet added.
  • 01/26/2011: The Regulatory Procedures Manual (RPM)has been revised and updated, as detailed below.

    Chapter 6 - Judicial Actions, Section 5 Prosecution

    • 6-5-3 Special Procedures and Considerations for Park Doctrine Prosecutions - this new section added.
    • 6-5-4 Communication Between OCI and Other FDA Components - this new section added.
    • 6-5-2 Office of Criminal Investigations (now titled Referral of Criminal Matters to the Office of Criminal Investigation) - updated to include instructions regarding communications between OCI and other FDA components.
    • 6-5-8 Contempt of Court; Violation of Probation (previously 6-5-6) - updated to add CMS instructions.
    • Editorial changes made to the following sections:
      • 6-5-5 Processing a Summary and Recommendation (previously 6-5-3);
      • 6-5-10 Referrals for Criminal Investigation (previously 6-5-8);
      • 6-5-12 Grand Jury Investigations and Secrecy (previously6-5-10); and
      • 6-5-13 Preparation of Summary and Recommendation(previously 6-5-12) paragraph 6. Prior Notice.
      • Moved information from previous6-5-11 Format for Summary& Recommendation to 6-5-13.

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