483
Gland Pharma Limited, Units I+II Pashamylaram SiteGland Pharma Limited, Units I+II Pashamylaram Site – FDA 483, Aug 2, 2024
Record Details
An FDA inspection of Gland Pharma Limited, Units I+II in Hyderabad, India, from July 25 to August 2, 2024, revealed significant deficiencies in the manufacturing of sterile drug products. The firm was cited for inadequate aseptic processing simulations, poor environmental monitoring practices, and a quality control unit that failed to properly follow procedures, leading to repeated equipment breakdowns and out-of-specification results.
- Inspection date
- August 2, 2024
- Product type
- drugs
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ID · ec9c17b8-eaa1-4d9f-aa4a-0631bfca1f54
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