Compliance
Regulatory Procedures Manual March 2004 |
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Regulatory Procedures Manual March 2004
Effective May 6, 2004
Chapter Descriptions
Entries
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We are in the process of supplementing all the
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files, please contact Paul Motise, Paul.Motise@fda.hhs.gov,
301-827-0383.
Introduction (PDF ,
63 kb) Ch. 1 – REGULATORY ORGANIZATION – An overview
of offices involved in compliance related functions within FDA. (PDF ,
448 kb) Ch. 2 – FDA AUTHORITY – Selected Amendments
to the Federal Food, Drug, and Cosmetic Act and other laws of interest.
(PDF ,
383 kb) Ch. 3 – COMMISSIONING AND WORK SHARING – Commissioning
of Federal, State, and local officials, acceptance of a state’s
commission, and work sharing initiatives. (PDF ,
854 kb)
Ch. 4 – ADVISORY ACTIONS – Procedures
for Warning Letters and Untitled Letters. (PDF ,
1.87 mb)
Ch. 5 – ADMINISTRATIVE ACTIONS – Procedures
for: Citation; Section 305 Meetings; Detentions of Foods; Administrative
Detentions of Devices; Revocation or Suspension of Biologic Licenses;
Orders for Retention, Recall, and/or Destruction of Human Tissue; and
Civil Money Penalties. (PDF ,
554 kb) Ch. 6 – JUDICIAL ACTIONS – Procedures for:
Seizures; Injunctions; Inspection Warrants; Search Warrants; Prosecution;
and Civil Penalties under Subchapter C of the Federal Food, Drug, and
Cosmetic Act. (PDF ,
1.8 mb)
Ch. 7 – RECALL PROCEDURES - Procedures for Agency
units to initiate, review, classify, publish, audit, and terminate
recall actions. (PDF ,
623 kb) Ch. 8 – EMERGENCY PROCEDURES - Emergency management
procedures for FDA’s headquarters and field personnel. (PDF ,
281 kb)
Ch. 9 – IMPORT OPERATIONS/ACTIONS – Includes:
Import Procedures; Coverage of Personal Importations; Importation
of Biological
Products; Warehouse Entries; Release Notices; Automatic Detentions; Notice
of Detention and Hearing; Responses to Notice of Detention and Hearing;
Notice of Refusal of Admission; Reconditioning; Supervisory Charges;
Bond Actions; Import Information Directives; Priority Enforcement Strategy
for Problem Importers; Import for Export; Importations for Trade
Shows/Fairs, Exhibits and Special Events; Communication Concerning
Assessment of Civil Monetary Penalties by U.S. Customs Service in
Cases Involving Imported Food; Notice of Sampling; and, Granting
and Denying Transportation and Exportation (T&E;) Entries.
(Chapter 9 is currently being revised. Until revisions have been completed,
please see the version of this chapter at: www.fda.gov/ora/compliance_ref/rpm_new2/ch9/default.htm)
Ch. 10 – OTHER PROCEDURES – Includes: Prior
Notice; Establishment Inspection Report (EIR) Conclusions and Decisions;
Interstate Travel Program (ITP) Classifications and Administrative Actions;
Reporting and Monitoring; Ad Hoc Committees; the Appeal Process; Expert
Support for Cases; Testimony; Production and Certification of Records;
and the Application Integrity Policy. (PDF ,
409 kb) Ch. 11 – GLOSSARY – Terms and Acronyms
used in the RPM. (PDF ,
235 kb) APPENDIX A - RPM CHANGE REQUEST FORM (PDF ,
70 kb)
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