FDA 483 - Livent USA Corp - February 03, 2020

Livent Corporation, an Active Pharmaceutical Ingredient (API) manufacturer in Bessemer City, NC, was cited for significant deficiencies in its quality control unit, out-of-specification laboratory results procedures, and complaint handling. The inspection revealed failures in tracking corrective/preventive actions, improper retesting by initial analysts, and inadequate complaint investigation processes. These issues indicate a systemic lack of adherence to established procedures and regulatory expectations.