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

During an FDA inspection conducted from November 2 to November 16, 2022, Regis Technologies, Inc., a drug substance manufacturer located in Morton Grove, IL, received a Form FDA 483 detailing significant observations. The inspection revealed two primary issues related to the firm's Quality Unit and adherence to Good Manufacturing Practices. Firstly, the Quality Unit failed to adequately manage production deviations. Specifically, it did not ensure all deviations were reported, evaluated, or that critical deviations, such as temperature excursions during the manufacturing of Active Pharmaceutical Ingredients (APIs) like Bromfenac and 4-Aminopyridine, were thoroughly investigated and documented. The company's validated Data Acquisition System either recorded temperatures outside specified ranges or failed to record them at all, without subsequent investigation. Secondly, the Quality Unit did not properly identify rejected materials. Inspectors observed multiple materials in a designated "rejected room" that lacked appropriate status labels, a direct violation of the company's own standard operating procedures for the approval and disposition of GMP products. These observations indicate areas where Regis Technologies, Inc. must implement corrective actions to ensure compliance with federal regulations enforced by the Food and Drug Administration, particularly concerning quality oversight and material control in drug substance manufacturing. The company is expected to address these findings to resolve the identified objectionable conditions and practices.