FDA (Food and Drug Administration)

What the FDA Is

The U.S. Food and Drug Administration regulates drugs, medical devices, food, and cosmetics, with authority to inspect and license manufacturing facilities both inside and outside the U.S. that intend to sell products into the American market.

Core Requirements for Drug Manufacturers

Facilities must comply with Current Good Manufacturing Practice (cGMP) under 21 CFR Parts 210 and 211, covering raw material control, manufacturing processes, validation, and complaint handling systems.

FDA Inspections

The FDA conducts both announced and unannounced inspections, reviewing manufacturing records, quality systems, and the actual production environment.

Consequences for Manufacturers

Deficiencies found during inspection can result in a Form 483 or Warning Letter, and uncorrected issues may lead to an Import Alert blocking future shipments.