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

LNK International, Inc., a manufacturer of human Over-The-Counter (OTC) drug products in Hauppauge, NY, underwent an FDA For-Cause inspection from June 11 to July 1, 2021. This inspection, conducted under Compliance Program 7356.002, focused on Good Manufacturing Practices (GMP) and served as a follow-up to a previous Warning Letter. At the conclusion, the FDA issued a five-item Form FDA 483, detailing significant observations. Key issues included a failure to clean equipment and utensils at appropriate intervals, which could compromise drug product safety and quality. The quality control unit's responsibilities and procedures were found not to be fully followed, and the firm's established procedures for handling drug product complaints were also not adhered to. Furthermore, laboratory controls lacked scientifically sound and appropriate test procedures to ensure drug product conformity. Lastly, employees were not adequately trained in their specific operations and current GMP requirements. These observations indicate a continued need for improvement in LNK International's adherence to regulatory standards under the Federal Food, Drug, and Cosmetic Act. The company's President committed to providing a written response to the FDA 483 within 15 working days of the inspection's close.