FDA 483 - Regis Technologies, Inc. - November 16, 2022
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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.
ID · 6de1b7f6-ab85-4578-8d83-6e955401ace2