Drug Quality Reporting System Inspections

ARTICLES

Drug Quality Reporting System (DQRS) (Medwatch Reports) – Inspection Techniques

Districts must complete, in a timely manner, their investigations and follow-up to those DQRS (MedWatch) reports, furnished by the Drug Surveillance and Data Reporting Branch (DSDRB, formerly within the Division of Compliance Risk Management and Surveillance (DCRMS)) Read More

Sampling

FDA investigators will collect samples to fully document serious deviations from cGMP and the likelihood of product quality problems as well as any labeling violations. Read More