483
Gland Pharma Limited, Units I+II Pashamylaram SiteGland Pharma Limited, Units I+II Pashamylaram Site – FDA 483, Nov 7, 2019
Record Details
An FDA inspection of Gland Pharma Limited, a parenteral drug manufacturer in Patancheru, India, revealed significant deficiencies across multiple areas. Observations included inadequate investigations into discrepancies and foreign materials, insufficient microbial control measures, and failures in laboratory controls for product quality and validation. Additionally, the firm was cited for not taking representative samples of components for testing.
- Inspection date
- November 7, 2019
- Product type
- drugs
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ID · 767d64c6-92ff-4f24-8fde-19bd74da6cdc
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