483
Cohance Lifesciences LimitedCohance Lifesciences Limited – FDA 483, Aug 20, 2019
Record Details
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.
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ID · 8c879e76-371d-4358-9d13-0c7e3eb72d67
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