FDA current Good Manufacturing Practices (cGMPs) and Quality System Regulations (QSRs) for Medical Devices

FDA requires that all regulated products be processed, packed, and held under sanitary conditions. The framework for FDA’s sanitation requirements are laid out in regulation but most of the substantive information is contained in various FDA guidance documents strewn about on the FDA website.

In addition to basic sanitation, FDA requires foods, drugs, medical devices, dietary supplements, and biological products be manufactured, packed, and held in conformance with cGMPs (or Quality Systems Regulations – QSRs – in the case of medical devices).

CGMP requirements are more fully described than the sanitation requirements in FDA regulations. A tremendous amount of substantive and product/process specific information, however, is hidden in FDA guidance documents or garnered by direct experience related to the FDA’s inspection process. FDA regularly inspects domestic and foreign facilities for compliance with cGMPs. In addition, after an inspection, FDA may issue a Notice of Inspectional Observations, an FD 483, or a warning letter or untitled letter. In these documents, FDA describes objectionable conditions observed during an inspection and alleged violations of FDA laws.

FDAImports.com consultants and affiliated attorneys assist clients in bringing their facilities into compliance with cGMP and QSR requirements in preparation for FDA inspections. We also assist clients by guiding their responses to FD 483s and warning letters.