FDA 483 - Yash Pharmaceuticals - September 03, 2019

Yash Pharmaceuticals, an OTC drug products manufacturer in Roorkee, India, was cited for significant deficiencies across its quality control, manufacturing, and laboratory operations. Observations included inadequate laboratory controls for product specifications and testing, lack of appropriate stability data for expiration dates, and failure to use tamper-evident packaging. Additionally, the firm had unvalidated and insufficient cleaning procedures, unqualified filling equipment, poor equipment maintenance, unsecured label storage, and a deficient quality control unit that failed to follow or adequately establish critical procedures.