Guideline

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Guide to Inspections of Medical Device Manufacturers
Internet:	http://www.fda.gov/ora/inspect_ref/igs/fordev.html
Origin/Publisher:	FDA http://www.fda.gov/ora/inspect_ref/igs/fordev.html
Content:	This guide was prepared to address concerns about consistency and uniformity of inspection between the domestic and foreign inspection programs. Consistency and uniformity of inspection and enforcement represent high priority goals for the Office of Regulatory Affairs (ORA). This guide sets forth clear instructions regarding the approach to the foreign inspection.
Status:	Guide to Inspections of
Document Type:	Guide to Inspections of