Medley Pharmaceuticals Limited – FDA 483, May 19, 2023

Medley Pharmaceuticals Limited, a drug manufacturer in Daman, India, was cited for significant deficiencies across its quality control and manufacturing operations. Observations included inadequate investigations into out-of-specification results and incidents, insufficient process control procedures, and failures in equipment cleaning validation. Additionally, the firm lacked proper environmental controls and procedures to prevent microbial contamination in non-sterile drug products.