Welcome to Inspection References

Updated: June 23, 2003

This page includes information provided to FDA investigators and inspectors to assist them in their daily activities.

• Field Management Directives

  The primary vehicle for distributing procedural information/policy on the management of Office of Regulatory Affairs (ORA) field activities.

• Guides to Inspections of...

  Guidance documents written to assist FDA personnel in applying FDA's regulations, policies and procedures during specific types of inspection or for specific manufacturing processes.

• IOM: Investigations Operations Manual

  March, 2004! Primary procedure manual for FDA personnel performing inspections and special investigations.

• Guide to International Inspections  and Travel

  Procedure manual for FDA personnel performing inspections and other FDA-related activities abroad.

• Inspection Technical Guides

  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.

• Medical Device GMP Reference Information

  (link to page maintained by CDRH)

• QS Regulation/Design Controls