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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Guide to Inspections of Foreign Pharmaceutical Manufacturers, (5/96)
Short Title:Foreign Inspection Guide
Internet:http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm075021.htm
Origin/Publisher:Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA
Content:This FDA Guide of the Office of Regulatory Affairs (ORA) deals with the logistical and technical aspects which an FDA investigator must take into account in the planning and conduct of foreign inspections .
Document Type:FDA Guide to Inspection