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Inspections, Compliance, Enforcement, and Criminal Investigations

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RPM News 2008

09/29/2008

Chapter 10 - Other Procedures

  • Section 10-8 Ad Hoc Committee, 10-8-5 Procedures - Revised to add a paragraph to describe requirements for requests for an appeal ad hoc committee.
  • Section 10-10 Expert Support for Cases:
    • 10-10-1 Purpose – Revised to add "or other specialized" support to the terms used to describe the types of expert support that may be needed for a case.
    • 10-10-2 Responsibility – Revised to further describe the role of centers in assuring FDA has expert support for a case.
    • 10-10-3 Criteria for Determining the Level of Expert Support - Revised to add "unprecedented issues" to the types of cases that should generally prompt centers to consider obtaining concurrence from experts.
06/24/2008

Chapter 4 - Advisory Actions

  • 4-1-10 Warning Letter Format
    Paragraph 13 – Revised to remove the words “issues and” in the sentence reading: “The issues and violations cited in this letter…”
  • Exhibit 4-1 –Procedures for Clearing FDA Warning Letters and Untitled Letters
    Revised to reflect the use of the Compliance Management System (CMS or MARCS-CMS). This application replaces the AIMS Violation Letter Tracking System (VLTS).
06/18/2008

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

  • Chapter 4 - Advisory Actions
    • Exhibit 4-1 – Procedures for Clearing FDA Warning Letters and Untitled Letters, Section 6.4.1 Model Letters and Audit Schedules
      Revised to add center concurrence “Tissue Residues Warning Letter for Producers who Medicate Animals” to the audit program.
03/06/2008
  • 03/05/2008:
    March 2008 edition of the Regulatory Procedures Manual (RPM) published; Chapters 1, 2, 4, 5, 6, 7, 8, 9, and 10 updated, as detailed below.
    • Chapter 1 - Regulatory Organization
      • Updated to reflect changes in organizational structure and phone numbers.
    • Chapter 2 - FDA Authority
      • 2-2 Selected Amendments to the Federal Food, Drug, and Cosmetic Act - Added summary of the "Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006."
    • Chapter 4 - Advisory Actions
      • 4-1-4 Center Concurrence and Letters Issued By Centers, paragraph 2. (CDER) - Replaced "Team Biologics (Core Team)" with "drug experience" reporting to correct terminology.
      • 4-1-5 Letters for Illegal Promotional Activities - Removed the instruction NOT to use Untitled Letters if a center would not support regulatory action.
      • 4-1-6 Multiple Center Review, paragraph 2 - Clarified that recommendations requiring review by more than one center should be reviewed by the centers concurrently, not sequentially.
      • 4-1-10 Warning Letter Format
        • paragraph 8 - Modified to reference new paragraph 13.
        • paragraph 13 - Added standardized language for the closing paragraphs of drug Warning Letters.
      • 4-1-14 Center for Biologics Evaluation and Research (CBER), paragraph 4. Warning Letter Recommendations, b. For Biological Drugs and Devices: - Added instruction that Warning Letter recommendations for therapeutic Biological Drugs are sent to CDER for concurrence.
      • 4-1-15 Center for Drug Evaluation And Research (CDER),
        • paragraph 2. Surveillance Inspections For Assessing Conformance With Adulteration Provisions of the Act, Including GMP - Replaced the reference to "Team Biologics" with "appropriately trained investigators, preferably Level III certified drug investigators..."
        • paragraph 3. Standard CDER Charges - Added "j. Adverse Drug Experience Reporting Violations and NDA Field Alert Reporting Violations" to provide language for section 505(k)(1) violations.
    • Chapter 5 - Administrative Actions
      • 5-5-2 Detention of Devices, paragraph 3. Detention Policy - Added statements regarding Administrative Detention of Devices, previously in "6-1-2 - General Guidelines For Seizures, 3. Voluntary Hold Or Embargo."
      • 5-6-5 (License) Revocation Procedures - Added reference to the WL procedures in Chapter 4, Ex. 4-1.
      • 5-6-7 (License) Suspension Procedures - Added a reference to the WL procedures in Ex. 4-1.
      • Updated IOM References throughout.
    • Chapter 6  - Judicial Actions
      • 6-1-2 General Guidelines For Seizure, paragraph 3. Voluntary Hold Or Embargo - Updated to add a reference to provisions for the Administrative Detention of Food.
      • 6-1-11 Disposition of Seized Articles, paragraph 5. Reconditioning Operations, c. Denaturing - Updated IOM reference.
      • 6-1-12 Costs Of Supervision - Clarified by using the term "disposal" rather than "conversion."
      • Exhibit 6-28, Rule 44. Proving an Official Record - Updated.
      • Exhibit 6-29, Rule 6. The Grand Jury - Updated.
    • Chapter 7 - Recall Procedures
      • 7-5-1 Firm Initiated Recalls, Paragraph 1. Recall Alert - Replaced the phrase "blood product recalls" with "biologics recalls" because 24 hour Alerts are not required for any biological product recalls for which CBER has issued an "alert to possible recall" to the field.
      • Attachment B - Recommendation for Recall Classification, Item 1. Product Description (INT), Trade Name..., paragraph "a. For each product, provide as applicable:" - Deleted the instruction "For biological recalls obtain the recalling firm's License/Registration number.  These items are to be inserted on the appropriate Center specific pages." because this information is not required in the RES system, and, therefore, no longer needs to be collected.
      • "International Relations Staff" was changed to "Office of International Programs" throughout the chapter.
    • Chapter 8 - Emergency Procedures
      • Updated IOM references throughout.
    • Chapter 9 - Import Operations and Actions
      • Includes recent editorial revisions, as detailed in the 02/19/2008 entry to the Revisions and Update List.
    • Chapter 10 - Other Procedures
      • 10-1 Communications - District and Center Responsibilities - Added.
      • 10-4 Inspection of Food Records - Sections 414(a) and 704(a) - Added.
02/20/2008

02/19/2008:
The Regulatory Procedures Manual (RPM) has been revised:

  • Chapter 9 (Rev. 2002) is currently under revision. The editorial revisions detailed below were made by DIOP in January 2008:
    • Subchapter 9-1, Import Procedures, Subchapter - Entries, Entry Processing, paragraph four (4) - Added instructional note to districts: "Note: As of this update additional "Other Government Agency" (OGA) flags have been added. If necessary, further guidance on OGA flags can be obtained by contacting the Division of Import Operations and Policy (DIOP) HFC-170." (To reflect changes to the FD Flags as a result of the BTA Amendments to the FFD&CA.)
    • Subchapter 9-1, Import Procedures, Subchapter – Entries, Formal Entries, paragraph one (1) - The following statement "All articles offered for import into the U.S. (entries) that have a value greater than $1200 (current) are considered by CBP to be formal entries." CHANGED TO "All articles offered for import into the U.S. (entries) that have a value greater than $2000 (current) are considered by CBP to be formal entries." (To reflect CBP's change in the dollar value limit for informal entries from $1200 to $2000.)
    • Subchapter 9-1, Import Procedures, Subchapter – Entries, Informal Entries, paragraph one (1) - The following statement "Under current CBP procedures, entries with a value less than $1200 do not require posting a redelivery bond." CHANGED TO "Under current CBP procedures, entries with a value less than $2000 do not require posting a redelivery bond." (To reflect CBP's change in the dollar value limit for informal entries from $1200 to $2000.)
    • Subchapter 9-3 - Removed and replaced with the statement: "RPM Subchapter 9-3, Importation of Biological Products was removed in January, 2008 per CBER request. For guidance regarding the importation of biological products, Districts should contact DIOP (HFC-170)." (To reflect Center requested removal of this subchapter.)
    • Subchapter 9-6, Detention without Physical Examination, Direct Reference Authority Recommendations, paragraph one (1) - "....are assumed to have CFSAN or CDRH concurrence" CHANGED TO "....are assumed to have appropriate Center concurrence..." (To reflect direct reference authorities from any Center.)
    • Subchapter 9-6, Detention without Physical Examination, Direct Reference Authority Recommendations, paragraph one (1) - "....recommendations for the automatic detention of latex condoms." CHANGED TO "....recommendations for detention without physical examination for salmonella in animal feed; and recommendations for detention without physical examination of latex condoms." (To reflect current terminology and add another example.)
    • Subchapter 9-6, Removal from Detention without Physical Examination, paragraph nine (9) - "....(Refer to Laboratory Manual (LM), for guidance regarding private laboratories.)" CHANGED TO "(Refer to ORA Laboratory Manual (LM), Volume III, Section 7) for guidance regarding private laboratories." (To reflect current name/structure of the manual.)
    • Subchapter 9-7, Notice of Detention and Hearing, Custody of Detained Shipments, paragraph two (2) - "Informal entries, those entries whose value is currently less than $1200, are usually not imported under bond." CHANGED TO "Informal entries, those entries whose value is currently less than $2000, are usually not imported under bond." (To reflect CBP's change in the dollar value limit for informal entries from $1200 to $2000.)
  • Throughout Chapter 9 -
    • All references to "Automatic Detention" CHANGED TO "Detention Without Physical Examination" (To reflect current terminology and agency policy.)
    • CBP form numbers "CF" CHANGED TO "CBP." (To reflect Customs and Border Protection's current and proper name.)
    • "Customs Service" CHANGED TO "2 Customs and Border Protection" or "CBP." (To reflect Customs and Border Protection's current and proper name.)
    • All references to "LISTS" DELETED. (To remove outdated reference.)
    • All references to "when OASIS is operational" DELETED. (To reflect the fact OASIS is operational in all Districts.)
    • All references to OASIS functionality that are not accurate were CHANGED TO reflect current OASIS processes. (To reflect the fact OASIS is operational in all Districts.)
    • Department of the Treasury CHANGED TO Department of Homeland Security. (To reflect current status of US Customs and Border Protection as a component agency of DHS.)
    • References to specific branches or offices within the Center for Foods and Applied Nutrition (CFSAN) or the Division of Field Science (DFS) DELETED since either the functions of the specific office or branch were transferred to another office or the specific office or branch is defunct.