Azurity Pharmaceuticals, Inc. – FDA EIR, Jul 26, 2019

An FDA inspection of CutisPharma, Inc., located in Wilmington, MA, was conducted from July 22 to July 26, 2019. The inspection focused on the company's compliance with Good Manufacturing Practices (GMP) for its drug compounding operations, specifically for the production of FIRVANQ. The regulatory framework governing this inspection falls under Section 501(a)(2)(B) of the Food, Drug and Cosmetic Act, which mandates that all drugs be manufactured in conformity with cGMP. The primary issue identified was a significant lapse in the firm's personnel training program. Investigators found that a temporary manufacturing operator had not received the necessary GMP training, which is a critical component for ensuring product quality and safety. This deficiency was highlighted during discussions with management, indicating a failure to adequately prepare personnel involved in manufacturing. Conversely, the inspection found no deficiencies in several other critical areas, including the Quality System, Materials System, Facilities & Equipment, Water System, Packaging and Labeling, and Laboratory Control System. In response to the identified issue, Mr. David Quadros, Vice President of Operations, acknowledged the finding. He committed to ensuring that all operating procedures are rigorously followed, addressing the training shortfall and reinforcing adherence to established protocols to maintain compliance with GMP regulations.