FDA Posts Updated Inspection Manual Chapter

October 25, 2017

The FDA recently updated its Investigations Operations Manual chapter on inspections of domestic and international sites.

The fifth chapter of the manual lays out the authority of agency investigators to enter and inspect facilities, the scope and approach of their inquiries, as well as their procedures for preparing Form 483s and post-inspection notification letters.

The 127-page chapter covers medical devices, drugs, and biologics, as well as food and tobacco product inspections conducted by the Office of Regulatory Affairs.

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