FDA 483 - Laurus Labs Limited - February 10, 2023

An FDA inspection of Laurus Labs Limited in Visakhapatnam, India, revealed two significant observations. The firm failed to maintain its manufacturing buildings in a clean and sanitary condition, evidenced by black discoloration on a HEPA filter. Additionally, the company did not thoroughly investigate unexplained discrepancies and out-of-specification results related to impurity contamination in drug products during stability studies.