FDA 483 - Chromcore Lifesciences LLP - November 08, 2024

An FDA inspection of Chromcore Lifesciences LLP, a control testing laboratory in Visakhapatnam, India, from November 6-8, 2024, identified one significant observation. The firm's procedures for equipment cleaning and maintenance, particularly for its water system used in glassware cleaning, were found to be deficient. This deficiency led to the visual observation of contamination in the water storage tank.