FDA 483 - Choksi Laboratories Limited - April 25, 2018

An FDA inspection of Choksi Laboratories Limited, a contract testing laboratory in Indore, India, revealed significant deficiencies in their quality control systems. The firm failed to adhere to its own written procedures for vendor re-assessment and did not record or justify deviations, particularly concerning unusual entries in HPLC instrument audit trails indicating modified results. These observations highlight concerns with data integrity and adherence to established quality processes.