Inspections, Compliance, Enforcement, and Criminal Investigations

RPM News 2009


Chapters 1, 2, 6 & 10 of the Regulatory Procedures Manual (RPM) were revised, as detailed below.

Chapter 1 – Regulatory Organization; 1-8-3 FDA Centers

  • Updated phone numbers in 2.Center for Drug Evaluation and Research (CDER) and 3. Center for Devices and Radiological Health (CDRH).

Chapter 2 - FDA Authority; 2-2 Selected Amendments to the Federal Food, Drug, and Cosmetic Act

  • Added 2-2-1 FDA Amendments Act of 2007.
  • Deleted previous 2-2-25 Drug Export Amendments Act of 1986.

Chapter 6 - Judicial Actions; 6-1 Seizure, 6-2 Injunctions, 6-3 Inspection Warrants, and 6-5 Prosecution

  • Added instructions for the use of CMS, an electronic case submission system.

Chapter 10 – Other Procedures; 10-1-3 Debarment - Notification Responsibilities of FDA Employees

  • New section; describes the requirement that employees notify ORA's Office of Enforcement of persons that may be subject to debarment under section 306 of the Act and provides procedures for this notification.


Chapter 7 of the Regulatory Procedures Manual (RPM) was updated, as detailed below.

Chapter 7 – Recall Procedures

  • 7-3-1 Responsibilities and Procedures - Office of Enforcement/Division of Compliance Management and Operations – Describes communications regarding recalls that may affect government agencies.
  • 7-3-3 Responsibilities and Procedures - Office of Enforcement/Division of Compliance Information and Quality Assurance - Describes responsibilities regarding above communications.
  • 7-4 Recall Enterprise System – States that actions that are determined to be Market Withdrawals or Safety Alerts by the districts prior to RES entry are not entered in RES. Recognizes that a form equivalent to the HHE form may be used.
  • 7-5-1 Firm Initiated Recalls
    • 1. Recall Alert – Updates instructions for transmitting this information.
    • 2. Recall Recommendation and Related Information – Updates instructions for transmitting this information. New paragraph was added to address recalls of foreign-manufactured products.
    • 5. Guidance to the Recalling Firm – Provides instructions on sub-recalls.
  • 7-6-4 Recall Strategy – Removes language re posting recalls to the web. States that needed corrections/modifications to a recalling firm’s recall strategy should be discussed with the firm prior to completing the recall classification in RES.
  • 7-7-2 Notification of Other Governments and Agencies; 2. Foreign, Military, and Other Federal Government Distribution – Replaces current opening paragraph with: “The district coordinator should submit a list of foreign, military, and other federal government consignees to OE/DCMO in RES with the Recall Recommendation submission, or, if this information is known at the time, with the 24 hour alert."
  • 7-8-3 State Audits – New section added to provide procedures for the use of state audits.
  • Attachment D - Health Hazard Evaluation Worksheet
    • Note - Recognizes that a form equivalent to the HHE form may be used.
    • 8. What is the hazard associated with the use of the product? – Substitutes the word “temporary” for “temporarily” in the phrase "temporarily or reversible (without medical intervention).”


Chapter 4 of the Regulatory Procedures Manual (RPM) was updated, as detailed below.

  • Chapter 4 - Advisory Actions
    • 4-1-8 Warning Letter Follow-Up - Revised to add new paragraph "2. Warning Letter Close-out Letter" to describe the conditions under which FDA may issue a close-out letter and the process for issuing these letters.


March 2009 edition of the Regulatory Procedures Manual (RPM) published; Introduction, and Chapters 1, 4, 5, 6, 8, and 10 updated, as detailed below.

  • Introduction
    • Deleted references to paper copies. The March 2009 edition is only available on the internet.
  • Chapter 1 - Regulatory Organization
    • Reflects organizational changes in CBER and CDER, and adds new phone numbers for CDER.
  • Chapter 4 - Advisory Actions
    • 4-1-4 Center Concurrence and Letters Issued by Centers – Updates CDER phone numbers.
    • 4-1-7 Time Frames – Asks that Warning Letter disapproval memos be provided to HFC-240.
    • 4-1-9 Firm Profile Updates in FACTS – Provides additional and updated information.
    • 4-1-11 Warning Letter Distribution and 4-1-13 Freedom of Information (FOI) - Reflects new procedures for sending Warning Letters to Division of Freedom of Information via the MARCS-CMS system; and eliminates the requirement to provide copies of Warning Letters to ORA HQ, Center compliance units, and district offices.
    • 4-1-15 (CDER) – Deletes a reference to a center jurisdiction change; acknowledges that a preapproval inspection may result in a recommendation concerning marketed, approved drugs; establishes a practice for the submission of regulatory action recommendations; and updates contact information.
    • 4-1-18 Tracking (WLs) and 4-2-2 Tracking (ULs), and Ex. 4-1 Procedures for Clearing FDA Warning Letters and Untitled Letters – Adds a reminder to update a firm's profile status information in FACTS.
    • 4-2 Untitled Letters - Requires center concurrence for Untitled Letters in the areas listed in section 4-1-4 (Warning Letters requiring center concurrence).
  • Chapter 5 - Administrative Actions
    • NOTE: - Adds reminder to update a firm's profile status information in FACTS.
    • 5-6-2 General (License Revocation or Suspension) – Refers to SMG 1410.203.
    • 5-8-1 Civil Money Penalty Authorities – Includes new authorities provided by FDAAA.
  • Chapter 6 - Judicial Actions
    • NOTE: - Adds reminder to update a firm's profile status information in FACTS.
  • Chapter 8 - Emergency Procedures
    • 8-2-1 Policy – Updates description of Emergency Operations Center (EOC) activities.
    • 8-4-1 Alert – Adds "4.Confirmation of declaration of pandemic influenza…”
    • 8-4-2 Presumptive – Adds "6.Confirmation of widespread outbreak in multiple locations overseas…”
    • 8-4-3 Confirmed – Adds "The first human case of pandemic influenza in U.S. is confirmed…”
    • 8-5-2 Emergency Alerts - Adds "pandemic influenza."
    • 8-6-1 FDA Emergency Operations Center, 2. EOC 24 Hour Telephone Contacts – Updates procedure.
    • 8-5-4 Emergency Management – Includes “managing on-scene operations.”
    • 8-5-5 Reporting 2. Hard Copy Reports - Updates addresses.
    • Various - Updates mail and e-mail addresses and includes minor editorial changes.
    • Deletes Exhibit 8-1 – FDA/CDC MOU.
  • Chapter 10 - Other Procedures
    • 10-1-1 Regulatory Actions that Require Center Concurrence – Adds reminder to update FACTS.
    • Section 10-5 Establishment Inspection Report (EIR) Conclusions and Decisions – Adds reminder to update FACTS.


Chapter 5 of Regulatory Procedures Manual (RPM) was updated as detailed below.

  • Chapter 5 - Administrative Actions
    • Chapter 5 was revised to add new Section 5-9 - Disqualification of Clinical Investigators


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