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Inspections, Compliance, Enforcement, and Criminal Investigations
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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
- Bioresearch Monitoring (BIMO)
- Devices/Radiological Health
- Drugs
- Food and Cosmetics
- Veterinary Medicine
Reference: FDA Freedom of Information Act Handbook for Requesting Information and Records from FDA
Foods and Cosmetics
| Program # | Compliance Program Title | On-line Availability |
|---|---|---|
| 7303.003 | Import Acidified and Low Acid Canned Foods Program | Link to CFSAN list |
| 7303.037 | Domestic and Imported Cheese and Cheese Products | Link to CFSAN list |
| 7303.039 | National Drug Residue Milk Monitoring Program | Link to CFSAN list |
| 7303.803 | Domestic Food Safety | Link to CFSAN list |
| 7303.803A | Domestic Acidified and Low-Acid Canned Foods | Link to CFSAN list |
| 7303.819 | Imported Foods - General Program | Link to CFSAN list |
| 7303.842 | Domestic Fish and Fishery Products Inspection Program | Link to CFSAN list |
| 7303.844 | Import Seafood Products | Link to CFSAN list |
| 7303.847 | Juice HACCP Inspection Program | not on-line |
| 7304.004 | Pesticides and Industrial Chemicals in Domestic Foods | Link to CFSAN list |
| 7304.016 | Pesticides and Industrial Chemicals in Imported Foods | Link to CFSAN list |
| 7304.018 | Chemotherapeutics in Seafood Compliance | Link to CFSAN list |
| 7304.019 | Toxic Elements in Food and Foodware Import and Domestic | Link to CFSAN list |
| 7304.839 | Total Diet Studies | Link to CFSAN list |
| 7307.001 | Mycotoxins in Domestic Foods | Link to CFSAN list |
| 7307.002 | Mycotoxins in Imported Foods | Link to CFSAN list |
| 7309.006 | Imported Foods - Food and Color Additives | Link to CFSAN list |
| 7318.002 | Retail Food Protection - State | Link to CFSAN list |
| 7318.003 | Milk Safety Program | Link to CFSAN list |
| 7318.004 | Molluscan Shellfish Evaluation | Link to CFSAN list |
| 7318.029 | Interstate Travel Program | Link to CFSAN list |
| 7321.002 | Medical Foods - Import and Domestic | Link to CFSAN list |
| 7321.005 | Domestic and Import NLEA, Nutrient Sample Analysis General Food Labeling Program | Link to CFSAN list |
| 7321.006 | Infant Formula Program - Import and Domestic | Link to CFSAN list |
| 7321.008 | Food Composition, Standards, Labeling And Economics Dietary Supplements - Import and Domestic | Link to CFSAN list |
| 7329.001 | Cosmetics Program - Domestic & Imports |
Link to CFSAN list |
Biologics
| Program # | Compliance Program Title | On-line Availability |
|---|---|---|
| 7341.002 | Inspection of Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) | Link to CBER list |
| 7341.002A | Inspection of Tissue Establishments | Link to CBER list |
| 7342.001 | Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors | Link to CBER list |
| 7342.002 | Inspection of Source Plasma Establishments | Link to CBER list |
| 7342.007 | Imported CBER-Regulated Products | Link to CBER list |
| 7342.007A | Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) | Link to CBER list |
| 7342.008 | Inspections of Licensed Viral Marker Test Kits | Link to CBER list or PDF (3129 kb) |
| 7345.848 | Inspection of Biological Drug Products | Link to CBER list |
BIMO
| Program # | Compliance Program Title | On-line Availability |
|---|---|---|
| 7348.001 | In Vivo Bioequivalence | HTML PDF(78 kb) |
| 7348.808 | Good Laboratory Practice (Nonclinical Laboratories) | HTML PDF(117 kb) |
| 7348.808A | Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections | HTML PDF(38 kb) |
| 7348.809 | Institutional Review Board | PDF(293 kb) |
| 7348.809A | Radioactive Drug Research Committee | not on-line |
| 7348.810 | Sponsors, Contract Research Organization and Monitors | HTML PDF(80 kb) |
| 7348.811 | Clinical Investigators | HTML PDF(2437 kb) |
Drugs
| Program # | Compliance Program Title | On-line Availability |
|---|---|---|
| 7346.832 | Pre-Approval Inspections/Investigations |
PDF(156kb) |
| 7346.843 | Post-Approval Audit Inspections | PDF(159kb) |
| 7352.002 | New Drugs (Rx) Not Covered by Approved NDA's | not on-line |
| 7352.004 | In Vitro Methods Development and Validation for Generic Drugs | not on-line |
| 7353.001 | Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations | HTML |
| 7356.002 | Drug Manufacturing Inspections | HTML PDF(80 kb) |
| 7356.002A | Sterile Drug Process Inspections | PDF(79 kb) |
| 7356.002B | Drug Repackers and Relabelers | PDF(189 kb) |
| 7356.002C | Radioactive Drugs | PDF(187 kb) |
| 7356.002E | Compressed Medical Gases | PDF(249 kb) |
| 7356.002F | Active Pharmaceutical Ingredients | PDF(252 kb) |
| 7356.002M | Inspections of Licensed Biological Therapeutic Drug Products | HTML PDF(89 kb) |
| 7356.008 | Postmarket Drug Product Surveys | not on-line |
| 7356.014 | Drug Listing | not on-line |
| 7356.014A | Drug Listing - Labeling Review | not on-line |
| 7356.020 | Compendial Monographs Evaluation and Development (CMED) | not on-line |
| 7356.020A | Compendial Methods Assessment | not on-line |
| 7356.021 | Drug Quality Reporting System NDA Field Alert Reporting | not on-line |
| 7356.022 | Enforcement of the Prescription Drug Marketing Act (PDMA) | not on-line |
| 7356.818 | Government-Wide Quality Assurance | not on-line |
| 7361.003 | OTC Drug Monograph Implementation | PDF(76 kb) |
| 7363.001 | Fraudulent Drugs | PDF(69 kb) |
Veterinary Medicine
| Program # | Compliance Program Title | On-line Availability |
|---|---|---|
| 7368.001 | Pre-Approval Inspection New Animal Drug Applications (NADA) Abbreviated New Animal Drug Applications (ANADA) | Link to CVM list |
| 7371.001 | Animal Drug Manufacturing Inspections | Link to CVM list |
| 7371.002 | Illegal Sales of Veterinary Prescription Drugs | Link to CVM list |
| 7371.003 | Feed Contaminants Program | Link to CVM list |
| 7371.004 | Feed Manufacturing Compliance Program | Link to CVM list |
| 7371.005 | Type A Medicated Articles | Link to CVM list |
| 7371.006 | Illegal Drug Residues in Meat & Poultry Program | Link to CVM list |
| 7371.007 | Imported Bulk New Animal Drugs | Link to CVM list |
| 7371.008 | National Drug Residue Milk Monitoring | Link to CVM list |
| 7371.009 | BSE/Ruminant Feed Ban Inspections | Link to CVM list |
Devices
| Program # | Compliance Program Title | On-line Availability |
|---|---|---|
| 7382.008 | Monitoring Devices of Foreign Origin Import | not on-line |
| 7382.013 | Conformance Assessment of Devices to Product Specifications in Pre-Market Notifications (510(k)s) | not on-line |
| 7382.845 | Inspection of Medical Device Manufacturers | HTML |
| 7383.001 | Medical Device Premarket Approval and Postmarket Inspections | not on-line |
| 7383.003 | 510(k) Premarket Approval Inspections | not on-line |
| 7385.014 | Mammography Facility Inspections | DOC (730 kb) |
| 7386.001 | Inspection and Field Testing of Radiation-Emitting Electronic Products | PDF(1190 kb) |
| 7386.003 | Field Compliance Testing of Diagnostic Medical X-Ray Equipment |
PDF (75 kb) DOC (143 kb) |
| Attachments A-C |
PDF(9 kb) DOC(28 kb) |
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| Attachment D |
PDF(25 kb) DOC (53 kb) |
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| Attachment E |
PDF(672 kb) DOC(126 kb) |
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| Attachment F |
PDF(30 kb) DOC(122 kb) |
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| Attachment G |
PDF(27 kb) DOC(61 kb) |
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| Attachments H-K |
PDF(22 kb) DOC(46 kb) |
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| Attachment L |
PDF(7 kb) DOC(24 kb) |
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| Attachment M |
PDF(37 kb) DOC(74 kb) |
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| 7386.003a | Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment | Link to CDRH List or PDF(3.51 kb) |
| 7386.006 | Compliance Testing of Electronic Products at WEAC | not on-line |
| 7386.007 | Imported Electronic Product | not on-line |
| 7386.007A | Imported Non-certified Radiation-Emitting Electronic Products (Special Exemption for Television Receivers, Microwave Ovens, and Certain Class I Laser Products | not on-line |
| 7386.008 | Medical Device and Radiological Health Use Control and Policy Implementation | not on-line |
| 7386.009 | Emergency Planning and Response Activities Part VI |
not on-line |
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