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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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RPM News 2007

10/01/2007

Update (October 1, 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.
04/30/2007 Exhibt 4.1 revised to add Seafood HACCP model letters to the audit review program
03/29/2007 RPM electronic (Internet) edition "March 2007" supersedes hardcopy "March 2006" for chapters as noted in Transmittal notice and in master list.