FDA 483 - LNK International, Inc. - July 01, 2021

LNK International, Inc. in Hauppauge, NY, was inspected by the FDA, resulting in five observations related to manufacturing and quality control deficiencies. Issues included inadequate equipment cleaning, failures in quality control unit procedures and process validation, non-compliance with complaint handling, insufficient laboratory controls for solution stability, and lack of proper employee training regarding GMP documentation. These observations indicate significant concerns with the firm's adherence to current good manufacturing practices.