FDA 483 - Regis Technologies, Inc. - November 16, 2022

Regis Technologies, Inc. in Morton Grove, IL, a drug substance manufacturer, received a Form 483 with two observations. The inspection revealed significant failures within the Quality Unit, including a failure to investigate temperature excursions and lack of documentation from their validated Data Acquisition System during Active Pharmaceutical Ingredient manufacturing. Additionally, the firm failed to properly label rejected materials, indicating a lapse in material control procedures.