FDA 483 - Choksi Laboratories Limited - September 06, 2019

Choksi Laboratories Limited, a control testing laboratory in Indore, India, received a Form 483 for significant data integrity issues and a pervasive lack of quality unit oversight. The inspection revealed fabricated documents, backdated records, incorrect test results, and a failure to investigate out-of-specification results and unknown impurities. These serious deficiencies indicate a systemic breakdown in cGMP compliance and data reliability.