FDA 483 - Cohance Lifesciences Limited - August 20, 2019

An FDA inspection of RA Chem Pharma Limited, a drug manufacturer in Hyderabad, Telangana, revealed significant deficiencies in their operations. The firm was cited for inadequate laboratory controls concerning sampling plans, issues with equipment design, cleaning, and qualification, and a lack of proper quality control unit oversight. These observations indicate a need for improved adherence to manufacturing and quality standards.