Choksi Laboratories Limited – FDA 483, Aug 20, 2026

Choksi Laboratories Limited, a control testing laboratory in Indore, India, received a Form 483 with four observations indicating significant quality system deficiencies. The inspection revealed failures in thorough out-of-specification (OOS) investigations, lack of robust analytical methods, inadequate environmental controls and QC unit procedures, and routine delays in instrument calibration. Two of the observations were repeats from a previous 2019 inspection, suggesting persistent issues.