483
Mylan Laboratories LimitedMylan Laboratories Limited – FDA 483, Jul 10, 2026
Record Details
An FDA inspection of Mylan Laboratories Limited, a sterile drug manufacturer in Bangalore, India, revealed significant deficiencies across multiple areas of its operations. Observations included inadequate aseptic practices, environmental monitoring, and batch record documentation. The firm also failed to adequately test incoming components, qualify a critical supplier, and conduct thorough investigations into product discrepancies, indicating potential risks to product quality and sterility.
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ID · ffbde96c-3131-4580-bd35-c7a49a38d215
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