FDA 483 - Oxalis Labs - August 02, 2019

Oxalis Labs, a drug manufacturer in Theda, India, was inspected by the FDA from July 29 to August 2, 2019. The inspection revealed significant issues with personnel adequacy for drug product processing and a failure to consistently investigate unexplained discrepancies, particularly regarding late stability sample testing. These observations indicate a lack of robust quality control and personnel management.