Strides Pharma Private Limited – FDA 483, Sep 11, 2026
Strides Pharma Private Limited in Chengalpattu, Tamil Nadu, India, received three observations during an FDA inspection, indicating significant deficiencies in their manufacturing and quality control systems. The firm failed to adequately validate manufacturing processes and requalify packaging systems, raising concerns about drug product quality. Additionally, the inspection highlighted repeat issues with the reliability of electronic records and the thoroughness of investigations into batch discrepancies and failures.
ID · bed61815-a10e-4f5f-a96f-e389ff3f44a7
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