FDA 483 - Nexus Pharmaceuticals, LLC - November 22, 2019

An FDA inspection of Nexus Pharmaceuticals Inc, a control testing laboratory in Lincolnshire, IL, identified deficiencies within its quality control unit. The firm failed to ensure that responsibilities and procedures were in writing and fully followed, particularly concerning the timely and thorough investigation of product quality complaints. Additionally, the complaint handling procedure did not identify the correct responsible party.