FDA 483 - Micro Labs Limited - May 12, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · a4a8e77c-fb4a-4614-a8f2-7367397b9ecd