FDA 483 - Oxalis Labs - June 02, 2023

Oxalis Labs, a contract manufacturer in Theda, India, was inspected by the FDA and cited for significant deficiencies. The firm failed to thoroughly review unexplained discrepancies, particularly numerous instrument errors, and did not implement preventive actions. Additionally, the inspection revealed a failure to submit a Field Alert Report for a distributed drug product with an observed impurity, and routine calibration and inspection of electronic equipment were not performed according to a written program.