483
Micro Labs LimitedMicro Labs Limited – FDA 483, May 12, 2023
Record Details
An FDA inspection of Micro Labs Limited, a sterile drug manufacturer in Bangalore, India, revealed significant deficiencies across laboratory controls and production systems. The firm failed to adequately investigate out-of-specification results and impurities, with one observation being a repeat finding. Additionally, the inspection identified issues with process validation, in-process controls, and the establishment of adequate written procedures for production and quality assurance.
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ID · a4a8e77c-fb4a-4614-a8f2-7367397b9ecd
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