FDA Inspections of Medical Device Manufacturers
Title:
FDA Inspections of Medical Device Manufacturers
Origin/Publisher:
FDA
Document Type:
Compliance Guide
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.