483
Optimus Pharma Private LimitedOptimus Pharma Private Limited – FDA 483, Dec 11, 2025
Record Details
Optimus Pharma Private Limited in Sangareddy, India, was cited for significant deficiencies in its drug manufacturing operations. The inspection revealed issues with equipment cleaning validation, annual reserve sample inspections, quality unit procedures for vendor qualification, investigation of discrepancies, and data backup for critical systems. These findings indicate a lack of robust quality control and adherence to cGMP regulations.
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ID · 38a0ccb1-9b83-4b62-a19b-742159d0b4a9
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