FDA 483 - Micro Labs Limited - February 07, 2025
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Micro Labs Limited, a finished drug products manufacturer in Bengaluru, India, was cited for significant quality system and laboratory control deficiencies during an FDA inspection. Inspectors found widespread data integrity issues, including the destruction of original GMP records, manipulation of test results, and use of unqualified reference standards. Additionally, the firm failed to maintain clean manufacturing equipment, indicating a severe lack of oversight across its operations.
ID · 5b636770-d5cf-4ce7-8e63-a3849feb4700