FDA 483 - Micro Labs Limited - December 08, 2023

Micro Labs Limited in Bangalore, India, was inspected by the FDA from December 4-8, 2023, revealing significant manufacturing deficiencies. The firm failed to use dedicated production areas and equipment, leading to potential cross-contamination risks for both U.S. and foreign market products. Additionally, the inspection cited inadequate laboratory testing to ensure product conformance and a failure to demonstrate the suitability of water used in manufacturing, specifically regarding Burkholderia Cepacia contamination.