Page 1 of 5 Home > Inspections, Compliance, Enforcement, and Criminal Investigations > Compliance Manuals > Compliance Program Guidance Manual Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Program Manual FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs neither create or confer any rights for, or on, any person and do not operate to bind FDA or the public. Alternative approaches may be used as long as said approaches satisfy the requirements of applicable statutes and regulations. These programs are intended for FDA personnel but are made available electronically to the public as they become available. Numerical listing of all FDA Compliance Programs with hyperlinks to those available electronically on FDA websites, organized by these program areas: Biologics 1 Bioresearch Monitoring (BIMO) 2 Devices/Radiological Health 3 Drugs 4 Food and Cosmetics 5 Veterinary Medicine 6 Reference: FDA Freedom of Information Act Handbook for Requesting Information and Records from FDA 7 Foods and Cosmetics 7303.003 Import Acidified and Low Acid Canned Foods Program Link to CFSAN list 8 7303.037 Domestic and Imported Cheese and Cheese Products Link to CFSAN list 9 7303.039 National Drug Residue Milk Monitoring Program Link to CFSAN list 10 7303.803 Domestic Food Safety Link to CFSAN list 11 7303.803A Domestic Acidified and Low-Acid Canned Foods Link to CFSAN list 12 7303.819 Imported Foods - General Program Link to CFSAN list 13 7303.842 Domestic Fish and Fishery Products Inspection Program Link to CFSAN list 14 7303.844 Import Seafood Products Link to CFSAN list 15 7303.847 Juice HACCP Inspection Program 7304.004 Pesticides and Industrial Chemicals in Domestic Foods Link to CFSAN list 16 7304.016 Pesticides and Industrial Chemicals in Imported Foods Link to CFSAN list 17 7304.018 Chemotherapeutics in Seafood Compliance Link to CFSAN list 18 7304.019 Toxic Elements in Food and Foodware Import and Domestic Link to CFSAN list 19 7304.839 Total Diet Studies Link to CFSAN list 20 7307.001 Mycotoxins in Domestic Foods Link to CFSAN list 21 7307.002 Mycotoxins in Imported Foods Link to CFSAN list 22 7309.006 Imported Foods - Food and Color Additives Link to CFSAN list 23 7318.002 Retail Food Protection - State Link to CFSAN list 24 7318.003 Milk Safety Program Link to CFSAN list 25 7318.004 Molluscan Shellfish Evaluation Link to CFSAN list 26 7318.029 Interstate Travel Program Link to CFSAN list 27 7321.002 Medical Foods - Import and Domestic Link to CFSAN list 28 7321.005 Domestic and Import NLEA, Nutrient Sample Analysis General Food Labeling Program Link to CFSAN list 29 7321.006 Infant Formula Program - Import and Domestic Link to CFSAN list 30 7321.008 Food Composition, Standards, Labeling And Economics Dietary Supplements - Import Link to CFSAN list 31 and Domestic 7329.001 Cosmetics Program - Domestic & Imports Link to CFSAN list 32 Page Top 33 Biologics 7341.002 Inspection of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list 34 7341.002A Inspection of Tissue Establishments Link to CBER list 35 7342.001 Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Link to CBER list 36 Contractors 7342.002 Inspection of Source Plasma Establishments Link to CBER list 37 7342.007 Imported CBER-Regulated Products Link to CBER list 38 7342.007A Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list 39 7342.008 Inspections of Licensed Viral Marker Test Kits Link to CBER list 40 or PDF (3129 kb) 7345.848 Inspection of Biological Drug Products Link to CBER list 41
Page 2 of 5 Page Top 42 BIMO 7348.001 In Vivo Bioequivalence HTML 43 PDF 44 (78 kb) 7348.808 Good Laboratory Practice (Nonclinical Laboratories) HTML 45 PDF 46 (117 kb) 7348.808A Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit HTML 47 PDF 48 (38 kb) Inspections 7348.809 Institutional Review Board PDF 49 (293 kb) 7348.809A Radioactive Drug Research Committee 7348.810 Sponsors, Contract Research Organization and Monitors HTML 50 PDF 51 (80 kb) 7348.811 Clinical Investigators HTML 52 PDF 53 (2437 kb) Drugs 7346.832 Pre-Approval Inspections/Investigations PDF 55 (156kb) 7346.843 Post-Approval Audit Inspections PDF 56 (159kb) 7352.002 Unapproved New Drugs (Marketed, Human, Prescription Drugs only) PDF 57 HTML 58 7352.004 In Vitro Methods Development and Validation for Generic Drugs 7353.001 Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations HTML 59 7356.002 Drug Manufacturing Inspections HTML 60 PDF 61 (80 kb) 7356.002A Sterile Drug Process Inspections PDF 62 (79 kb) 7356.002B Drug Repackers and Relabelers PDF 63 (189 kb) 7356.002C Radioactive Drugs PDF 64 (187 kb) 7356.002E Compressed Medical Gases PDF 65 (249 kb) 7356.002F Active Pharmaceutical Ingredients PDF 66 (252 kb) 7356.002M Inspections of Licensed Biological Therapeutic Drug Products HTML 67 PDF 68 (89 kb) 7356.008 Postmarket Drug Product Surveys 7356.014 Drug Listing 7356.014A Drug Listing - Labeling Review 7356.020 Compendial Monographs Evaluation and Development (CMED) 7356.020A Compendial Methods Assessment 7356.021 Drug Quality Reporting System NDA Field Alert Reporting 7356.022 Enforcement of the Prescription Drug Marketing Act (PDMA) 7356.818 Government-Wide Quality Assurance 7361.003 OTC Drug Monograph Implementation PDF 69 (76 kb) 7363.001 Fraudulent Drugs PDF 70 (69 kb) Veterinary Medicine 7368.001 Pre-Approval Inspection New Animal Drug Applications (NADA) Abbreviated New Animal Link to CVM list 72 Drug Applications (ANADA) 7371.001 Animal Drug Manufacturing Inspections Link to CVM list 73 7371.002 Illegal Sales of Veterinary Prescription Drugs Link to CVM list 74 7371.003 Feed Contaminants Program Link to CVM list 75 7371.004 Feed Manufacturing Compliance Program Link to CVM list 76 7371.005 Type A Medicated Articles Link to CVM list 77 7371.006 Illegal Drug Residues in Meat & Poultry Program Link to CVM list 78 7371.007 Imported Bulk New Animal Drugs Link to CVM list 79 7371.008 National Drug Residue Milk Monitoring Link to CVM list 80 7371.009 BSE/Ruminant Feed Ban Inspections Link to CVM list 81 Page Top 54 Page Top 71 Page Top 82 Devices 7382.008 Monitoring Devices of Foreign Origin Import 7382.013 Conformance Assessment of Devices to Product Specifications in Pre-Market Notifications (510(k)s) 7382.845 Inspection of Medical Device Manufacturers HTML 83 7383.001 Medical Device Premarket Approval and Postmarket Inspections 7383.003 510(k) Premarket Approval Inspections 7385.014 Mammography Facility Inspections DOC 84 (730 kb) 7386.001 Inspection and Field Testing of Radiation- Emitting Electronic Products PDF 85 (1190 kb) 7386.003 Field Compliance Testing of Diagnostic Medical X-Ray Equipment PDF 86 (75 kb) DOC 87 (143 kb) Attachments A-C PDF 88 (9 kb) DOC 89 (28 kb) Attachment D PDF 90 (25 kb)
Page 3 of 5 Attachment E Attachment F Attachment G Attachments H-K Attachment L DOC 91 (53 kb) PDF 92 (672 kb) DOC 93 (126 kb) PDF 94 (30 kb) DOC 95 (122 kb) PDF 96 (27 kb) DOC 97 (61 kb) PDF 98 (22 kb) DOC 99 (46 kb) PDF 100 (7 kb) DOC 101 (24 kb) PDF 102 (37 kb) Attachment M DOC 103 (74 kb) Inspection of Domestic and Foreign 7386.003a Link to CDRH List 104 Manufacturers of Diagnostic X Ray Equipment or PDF 105 (3.51 kb) Compliance Testing of Electronic Products at 7386.006 WEAC 7386.007 Imported Electronic Product Imported Non-certified Radiation-Emitting Electronic Products (Special Exemption for 7386.007A Television Receivers, Microwave Ovens, and Certain Class I Laser Products Medical Device and Radiological Health Use 7386.008 Control and Policy Implementation Emergency Planning and Response Activities 7386.009 Part VI Links on this page: 1. http://www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/ucm2005382.htm#biologics 2. http://www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/ucm2005382.htm#bimo 3. http://www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/ucm2005382.htm#devices 4. http://www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/ucm2005382.htm#drugs 5. http://www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/ucm2005382.htm#foods 6. http://www.fda.gov/iceci/compliancemanuals/complianceprogrammanual/ucm2005382.htm#veterinary 7. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 8. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 9. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 10. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 11. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 12. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 13. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 14. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 15. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 16. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 17. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 18. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 19. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 20. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 21. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 22. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 23. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 24. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 25. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 26. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 27. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 28. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 29. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 30. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 31. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm 32. http://www.fda.gov/food/guidancecomplianceregulatoryinformation/complianceenforcement/ucm071496.htm
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