FDA 483 - ISP Chemicals LLC - December 02, 2021

ISP Chemicals LLC in Columbus, Ohio, a non-sterile API manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in laboratory controls, including unestablished test method accuracy and inadequate stability testing for Flunixin Meglumine API. Additionally, the Quality Control unit lacked proper authority to review records and failed to qualify suppliers for critical components.