FDA 483 - Intermed Laboratories Private Limited - March 17, 2023

Intermed, a drug manufacturer in Chennai, India, was cited for significant deficiencies in its quality control unit, including inadequate acceptance criteria for testing, lack of method validation, and insufficient in-process controls. The inspection also revealed failures in thoroughly reviewing out-of-specification results, incomplete batch production records, and inadequate storage controls for labeling materials. These issues indicate a lack of robust quality systems to ensure drug product quality and compliance.