FDA 483 - PROXIMAGEN LLC - March 05, 2019

An FDA inspection of Proximagen LLC in Plymouth, MN, revealed multiple deficiencies in the firm's quality system and manufacturing controls. The company failed to establish adequate design control procedures for its Nayzilam device, lacked proper monitoring for process parameters, and did not have procedures for identifying valid statistical techniques. Additionally, a management representative was not timely appointed, and quality agreements with contract manufacturers were not clearly defined regarding services.