FDA 483 - Orean Personal Care Ltd - February 20, 2026

Orean Personal Care Ltd, an OTC drug product manufacturer in Cleckheaton, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to establish and follow adequate procedures for equipment cleaning validation, quality control unit responsibilities, laboratory controls including water system monitoring and test method validation, and process validation. Additionally, the company did not thoroughly investigate out-of-specification results for distributed products and exhibited poor material handling practices, indicating a broad lack of GMP compliance.