FDA 483 - Micro Labs Limited - February 09, 2024

Micro Labs Limited received a Form 483 with significant observations related to quality control, equipment cleaning, laboratory controls, and employee training. The firm released drug products with valid Out-of-Specification results, failed to adequately clean manufacturing equipment leading to potential cross-contamination, and delayed reporting Field Alert Reports for over 1.5 years. These issues indicate a systemic breakdown in quality oversight and adherence to cGMP regulations, posing risks to drug product safety and purity in the US market.