FDA 483 - Micro Labs Limited - February 09, 2024

During an inspection from January 29 to February 9, 2024, the FDA issued a Form 483 to Micro Labs Limited, an OSD Drug Products Manufacturer in Verna, Goa, India. The inspection revealed significant deviations from Current Good Manufacturing Practices (cGMP), indicating a deficient quality system and inadequate facility and equipment controls. Key observations included the Quality Control Unit's failure to follow established procedures, leading to the release of numerous drug product batches with confirmed Out-of-Specification (OOS) results into the U.S. market between October 2019 and December 2023. This necessitated recalls during the inspection. The firm also lacked proper oversight of equipment cleaning, with significant build-up of powdery materials, and evidence of microbial and mold growth in non-dedicated manufacturing equipment, posing a high risk of cross-contamination. Swab samples from equipment showed drug substances at levels far exceeding acceptance limits, prompting Field Alert Reports. Further issues involved the inadequacy of laboratory controls, including non-stability indicating test methods for related substances and scientifically unsound procedures for swab sample analysis. Deficient employee training for critical operations, such as pipetting and swab collection techniques, also contributed to unreliable data. A critical finding was the company’s over 1.5-year delay in submitting Field Alert Reports and initiating market actions despite discovering substantial contamination in equipment, potentially leaving compromised drug products in the U.S. market. Micro Labs Limited is required to conduct thorough investigations into these observations, implement robust corrective and preventive actions, and ensure all manufacturing processes, quality controls, and personnel training comply with cGMP regulations to safeguard product quality and patient safety.