483
Gland Chemical Private LimitedFDA 483 - Gland Chemical Private Limited - November 27, 2025
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An FDA inspection of Gland Chemicals Private Limited in Chennai, India, revealed significant deficiencies in their sterile drug manufacturing operations. The firm failed to prevent cross-contamination, adequately validate aseptic processes, maintain proper laboratory controls, and ensure data integrity. These issues indicate a high risk to the sterility and quality of their drug products.
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