FDA Drug Quality Sampling and Testing Programs

Assurentry Team · February 2026

Why FDA Samples Drugs

FDA samples and tests drugs to verify identity, strength, purity, and quality. Sampling occurs at manufacturing sites, distributors, and import entry. Results inform recalls, import refusals, and enforcement actions.

Drug Quality Sampling Program

ORA (Office of Regulatory Affairs) and CDER coordinate sampling of finished drug products, APIs, and OTC monograph drugs. Samples are analyzed in FDA or contract laboratories. Firms must provide product and manufacturing documentation upon request.

Testing and Analytical Methods

FDA uses compendial methods (USP, etc.) and validated methods to test for identity, assay, dissolution, and contamination. Out-of-specification results trigger further investigation and potential enforcement.

Import Testing and Refusals

Imported drugs may be sampled at entry. Adulterated or misbranded products can be refused. Ensure your SPL listings and manufacturing documentation support release.

What Manufacturers Should Do

Maintain robust cGMP systems, validate methods, and retain samples. Be ready to provide batch records and test data. Strong internal quality systems reduce sampling risk.