483
Cipla LimitedFDA 483 - Cipla Limited - November 13, 2024
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An FDA inspection of CIPLA Limited in Bengaluru, India, revealed significant deficiencies across multiple quality systems for API manufacturing. Issues included inadequate equipment cleaning and maintenance, poorly defined critical process parameters, and insufficient quality unit oversight. The firm also failed to conduct comprehensive investigations into packaging material complaints and lacked proper laboratory controls.
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ID · 53061bbf-ca16-42ce-b780-25e91280d57b