Numerical listing of all FDA Compliance Programs with hyperlinks to
those available electronically on FDA websites, organized by these program areas:
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 (3129 kb) |
7345.848 |
Inspection of Biological Drug Products |
Link to CBER list |
Program # |
Compliance Program Title |
On-line Availability |
7346.832 |
Pre-Approval Inspections/Investigations |
(156kb) |
7346.843 |
Post-Approval Audit Inspections |
(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 |
|
7356.002 |
Drug Manufacturing Inspections |
(80 kb) |
7356.002A |
Sterile Drug Process Inspections |
(79 kb) |
7356.002B |
Drug Repackers and Relabelers |
(189 kb) |
7356.002C |
Radioactive Drugs |
(187 kb) |
7356.002E |
Compressed Medical Gases |
(249 kb) |
7356.002F |
Active Pharmaceutical Ingredients |
(252 kb) |
7356.002M |
Inspections of Licensed Biological Therapeutic
Drug Products |
(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 |
(76 kb) |
7363.001 |
Fraudulent Drugs |
(69 kb) |
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 |
|
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 |
(497 kb) (730 kb) |
7386.001 |
Inspection and Field Testing
of Radiation-Emitting Electronic Products |
(1190 kb) |
7386.003 |
Field Compliance Testing of Diagnostic
Medical X-Ray Equipment |
(75 kb) (143 kb) |
Attachments A-C |
(9 kb)
(28 kb) |
Attachment D |
(25 kb)
(53 kb) |
Attachment E |
(672 kb)
(126 kb) |
Attachment F |
(30 kb)
(122 kb) |
Attachment G |
(27 kb)
(61 kb) |
Attachments H-K |
(22 kb)
(46 kb) |
Attachment L |
(7 kb)
(24 kb) |
Attachment M |
(37 kb)
(74 kb) |
7386.003a |
Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment |
Link to CDRH List
or (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 |