483
Gland Pharma LimitedGland Pharma Limited – FDA 483, Nov 1, 2019
Record Details
An FDA inspection of Gland Pharma Limited, a sterile drug manufacturer in Visakhapatnam, revealed two significant observations. The firm failed to adequately validate its aseptic and sterilization processes, raising concerns about microbiological contamination control. Additionally, investigations into unexplained discrepancies lacked thoroughness, conclusions, and follow-up actions.
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ID · cb276665-92aa-427d-b63e-73e0bdec767a
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