This page includes information provided to
FDA investigators and inspectors to assist them in their daily activities.
The primary vehicle for distributing procedural information/policy on the management of
Office of Regulatory Affairs (ORA) field activities.
Guidance documents written to assist FDA personnel in applying FDA's regulations,
policies and procedures during specific types of inspection or for specific manufacturing
Primary procedure manual for FDA personnel performing
inspections and special investigations.
Procedure manual for FDA personnel performing inspections and other FDA-related activities
Guidance documents that provide FDA personnel with technical background in a specific
piece of equipment. or a specific manufacturing or laboratory procedure, or a specific
inspectional technique, etc.
(link to page maintained by CDRH)