FDA Compliance Programs

When FDA inspects a factory, lab or clinical trial, its investigators follow a written compliance program for that kind of work. These are the programs FDA publishes, with the document for each.

The 50 compliance programs FDA publishes for drugs, devices, biologics and clinical research. Each one tells investigators what to inspect, what samples to take and when to recommend action.

Drugs (CDER): 27 programs
Devices (CDRH): 9 programs
Biologics (CBER): 6 programs
Clinical research (BIMO): 11 programs
Newest page update: Oct 15, 2026

Drugs (CDER)

FDA's page, updated Sep 16, 2026

		Document
7346.832	Preapproval Inspections	FDA PDF
7346.832M	Prelicense and Preapproval Inspections of CDER-Regulated Biological Product Manufacturers	FDA PDF
7348.001	In Vivo Bioequivalence	FDA PDF
7348.809A	Radioactive Drug Research Committee	FDA PDF
7352.002	Unapproved New Drugs (Marketed, Human, Prescription Drugs only)	FDA PDF
7352.004	In Vitro Methods Development and Validation for Generic Drugs	Not online
7353.001	Postmarketing Adverse Drug Experience (PADE) Reporting Inspections	FDA PDF
7356.000	Inspections of CDER-led or CDRH-led Combination Products	FDA PDF
7356.002	Drug Manufacturing Inspections	FDA PDF
7356.002A	Sterile Drug Process Inspections	FDA PDF
7356.002B	Drug Repackers and Relabelers	FDA PDF
7356.002C	Radioactive Drugs	FDA PDF
7356.002F	Active Pharmaceutical Ingredients	FDA PDF
7356.002M	Surveillance Inspections of Protein Drug Substance Manufacturers	FDA PDF
7356.002P	Positron Emission Tomography	FDA PDF
7356.008	Drug Quality Sampling and Testing - Human Drugs	FDA PDF
7356.013	Import Human Drug Operations	Not online
7356.014	Drug Listing	Not online
7356.014A	Drug Listing - Labeling Review	Not online
7356.020	Compendial Monographs Evaluation and Development (CMED)	Not online
7356.020A	Compendial Methods Assessment	Not online
7356.021	Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)	FDA PDF
7356.022	Enforcement of the Drug Sample Distribution Requirements of the Prescription Drug Marketing Act (PDMA)	FDA PDF
7356.040	Outsourcing Facility Inspections	FDA PDF
7356.843	Postapproval Inspections	FDA PDF
7361.003	OTC Drug Monograph Implementation	FDA PDF
7363.001	Fraudulent Drugs	FDA PDF

Devices (CDRH)

FDA's page, updated May 12, 2026

		Document
7356.000	Inspections of CDER-led or CDRH-led Combination Products	FDA PDF
7382.850	Inspection of Medical Device Manufacturers	FDA PDF
7385.014	Mammography Facility Inspections	FDA PDF
7386.001	Inspection and Field Testing of Radiation-Emitting Electronic Products (updated 01/01/23)	FDA PDF
7386.003	Field Compliance Testing of Diagnostic Medical X-Ray Equipment	FDA PDF
7386.006	Compliance Testing of Electronic Products at WEAC (updated 01/01/23)	FDA PDF
7386.007	Imported Electronic Product	Not online
7386.008	Medical Device and Radiological Health Use Control and Policy Implementation	Not online
7386.009	Emergency Planning and Response Activities	Not online

Biologics (CBER)

FDA's page, updated Jun 12, 2025

		Document
7341.002	Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)	FDA PDF
7342.001	Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors	FDA PDF
7342.002	Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors	FDA PDF
7342.007	Imported CBER-Regulated Products	FDA PDF
7342.008	Inspection of Licensed In-Vitro Diagnostic (IVD) Devices	FDA PDF
7345.848	Inspection of Biological Drug Products	FDA PDF

Clinical research (BIMO)

FDA's page, updated Oct 15, 2026

		Document
7348.003	In Vivo Bioavailability-Bioequivalence Studies - Clinical	FDA PDF
7348.004	In Vivo Bioavailability-Bioequivalence Studies - Analytical	FDA PDF
7348.007	Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies	FDA PDF
7348.808	Good Laboratory Practice (Nonclinical Laboratories)	FDA PDF
7348.808A	Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections	FDA page
7348.809	Institutional Review Board	FDA PDF
7348.809A	Radioactive Drug Research Committee	FDA PDF
7348.810	Sponsors and Contract Research Organizations	FDA PDF
7348.811	Clinical Investigators and Sponsor-Investigators	FDA page
7353.001	Postmarketing Adverse Drug Experience (PADE) Reporting Inspections	FDA PDF
7353.001C	Risk Evaluation and Mitigation Strategies (REMS) Reporting Inspections	FDA PDF

Some programs appear under two centers (combination products, PADE reporting). Programs FDA lists as not available online have no document. Since February 2, 2026, device inspections follow 7382.850 under the QMSR, replacing QSIT (7382.845) and the PMA inspection program (7383.001). Refreshed weekly. FDA compliance program pages (CDER, CDRH, CBER, BIMO)