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1 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 Import Acidified and Low Acid Canned Foods Program Link to CFSAN list Domestic and Imported Cheese and Cheese Products Link to CFSAN list National Drug Residue Milk Monitoring Program Link to CFSAN list Domestic Food Safety Link to CFSAN list A Domestic Acidified and Low-Acid Canned Foods Link to CFSAN list Imported Foods - General Program Link to CFSAN list Domestic Fish and Fishery Products Inspection Program Link to CFSAN list Import Seafood Products Link to CFSAN list Juice HACCP Inspection Program Pesticides and Industrial Chemicals in Domestic Foods Link to CFSAN list Pesticides and Industrial Chemicals in Imported Foods Link to CFSAN list Chemotherapeutics in Seafood Compliance Link to CFSAN list Toxic Elements in Food and Foodware Import and Domestic Link to CFSAN list Total Diet Studies Link to CFSAN list Mycotoxins in Domestic Foods Link to CFSAN list Mycotoxins in Imported Foods Link to CFSAN list Imported Foods - Food and Color Additives Link to CFSAN list Retail Food Protection - State Link to CFSAN list Milk Safety Program Link to CFSAN list Molluscan Shellfish Evaluation Link to CFSAN list Interstate Travel Program Link to CFSAN list Medical Foods - Import and Domestic Link to CFSAN list Domestic and Import NLEA, Nutrient Sample Analysis General Food Labeling Program Link to CFSAN list Infant Formula Program - Import and Domestic Link to CFSAN list Food Composition, Standards, Labeling And Economics Dietary Supplements - Import Link to CFSAN list 31 and Domestic Cosmetics Program - Domestic & Imports Link to CFSAN list 32 Page Top 33 Biologics Inspection of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list A Inspection of Tissue Establishments Link to CBER list Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Link to CBER list 36 Contractors Inspection of Source Plasma Establishments Link to CBER list Imported CBER-Regulated Products Link to CBER list A Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) Link to CBER list Inspections of Licensed Viral Marker Test Kits Link to CBER list 40 or PDF (3129 kb) Inspection of Biological Drug Products Link to CBER list 41
2 Page 2 of 5 Page Top 42 BIMO In Vivo Bioequivalence HTML 43 PDF 44 (78 kb) Good Laboratory Practice (Nonclinical Laboratories) HTML 45 PDF 46 (117 kb) A Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit HTML 47 PDF 48 (38 kb) Inspections Institutional Review Board PDF 49 (293 kb) A Radioactive Drug Research Committee Sponsors, Contract Research Organization and Monitors HTML 50 PDF 51 (80 kb) Clinical Investigators HTML 52 PDF 53 (2437 kb) Drugs Pre-Approval Inspections/Investigations PDF 55 (156kb) Post-Approval Audit Inspections PDF 56 (159kb) Unapproved New Drugs (Marketed, Human, Prescription Drugs only) PDF 57 HTML In Vitro Methods Development and Validation for Generic Drugs Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations HTML Drug Manufacturing Inspections HTML 60 PDF 61 (80 kb) A Sterile Drug Process Inspections PDF 62 (79 kb) B Drug Repackers and Relabelers PDF 63 (189 kb) C Radioactive Drugs PDF 64 (187 kb) E Compressed Medical Gases PDF 65 (249 kb) F Active Pharmaceutical Ingredients PDF 66 (252 kb) M Inspections of Licensed Biological Therapeutic Drug Products HTML 67 PDF 68 (89 kb) Postmarket Drug Product Surveys Drug Listing A Drug Listing - Labeling Review Compendial Monographs Evaluation and Development (CMED) A Compendial Methods Assessment Drug Quality Reporting System NDA Field Alert Reporting Enforcement of the Prescription Drug Marketing Act (PDMA) Government-Wide Quality Assurance OTC Drug Monograph Implementation PDF 69 (76 kb) Fraudulent Drugs PDF 70 (69 kb) Veterinary Medicine Pre-Approval Inspection New Animal Drug Applications (NADA) Abbreviated New Animal Link to CVM list 72 Drug Applications (ANADA) Animal Drug Manufacturing Inspections Link to CVM list Illegal Sales of Veterinary Prescription Drugs Link to CVM list Feed Contaminants Program Link to CVM list Feed Manufacturing Compliance Program Link to CVM list Type A Medicated Articles Link to CVM list Illegal Drug Residues in Meat & Poultry Program Link to CVM list Imported Bulk New Animal Drugs Link to CVM list National Drug Residue Milk Monitoring Link to CVM list BSE/Ruminant Feed Ban Inspections Link to CVM list 81 Page Top 54 Page Top 71 Page Top 82 Devices Monitoring Devices of Foreign Origin Import Conformance Assessment of Devices to Product Specifications in Pre-Market Notifications (510(k)s) Inspection of Medical Device Manufacturers HTML Medical Device Premarket Approval and Postmarket Inspections (k) Premarket Approval Inspections Mammography Facility Inspections DOC 84 (730 kb) Inspection and Field Testing of Radiation- Emitting Electronic Products PDF 85 (1190 kb) 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)
3 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 a Link to CDRH List 104 Manufacturers of Diagnostic X Ray Equipment or PDF 105 (3.51 kb) Compliance Testing of Electronic Products at WEAC Imported Electronic Product Imported Non-certified Radiation-Emitting Electronic Products (Special Exemption for A Television Receivers, Microwave Ovens, and Certain Class I Laser Products Medical Device and Radiological Health Use Control and Policy Implementation Emergency Planning and Response Activities Part VI Links on this page:
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