483
Medley Pharmaceuticals LimitedFDA 483 - Medley Pharmaceuticals Limited - May 19, 2023
Record Details
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.
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ID · 64d9845e-fe91-4da9-9182-c71512cd4f3d