483
Gland Chemical Private LimitedFDA 483 - Gland Chemical Private Limited - November 27, 2025
Record Details
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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ID · 9fb83319-8498-422d-b8f1-e2e90a67fa18