FDA Inspections Procedure | MFG104

FDA Inspections Procedure

Responsible company officials who are in positions of authority in regulated firms have a primary legal duty to implement whatever measures are necessary to ensure that their products, facilities and operations are in compliance with the law. The law presumes these individuals are fully aware of their responsibilities.

As such, your company will not only ensure compliance with GMP but will plan and prepare for factory inspections by FDA auditors and will assist and coordinate the investigation to provide a smooth, timely process that accurately portrays your company’s operations.

The FDA Inspections Procedure outlines an inspection plan for FDA GMP audits of our factory.This statement applies to all factory inspections by the FDA and affects all employees involved with the inspection process. (16 pages, 3726 words)

FDA Inspections Definitions:

GMP – Good Manufacturing Practice.

Good Manufacturing Practices (GMP) regulation – Requires that manufacturers of medical devices intended for commercial distribution in the USA establish and follow a quality assurance program. See FD&C Act, section 520; also see 21 CFR 360j (f).

FDA Inspections Procedure Activities

• Audit Selection Process
• Inspection Announcement Protocol
• Conduct During the Inspection
• Areas of Inspection
• Close-Out Meeting and Post-Inspection

FDA Inspections Procedure References

• State and Regulatory Requirements

FDA Inspections Procedure Forms

• Triggers & Decision Points for GMP Inspections
• Excerpts of the FDA’s Two Track GMP Inspection Strategy and Compliance Program