FDA 483 - Canton Laboratories Private Ltd. - November 21, 2019

Canton Laboratories Private Limited, an API manufacturer in Vadodara, India, received a Form FDA 483 with nine observations during an inspection from November 18-21, 2019. The firm was cited for significant deficiencies across its quality systems, facilities, equipment, and laboratory controls, including inadequate handling of returned APIs, poor document control, and issues with equipment calibration and computerized systems. Many of these observations were repeats from a previous 2015 FDA inspection, indicating persistent non-compliance with cGMP regulations.