FDA 483 - Neogen Corporation - December 21, 2023

An FDA inspection of Neogen Corporation in Lexington, KY, a human and animal drug manufacturer, revealed significant deficiencies in equipment maintenance and microbial control. Observations included inadequate qualification and maintenance of the water system used for Pyrantel Pamoate production, specifically regarding UV bulb changes and filter capacity. Additionally, the firm failed to establish procedures for testing objectionable microorganisms, specifically Burkholderia cepacia complex, in its finished drug product.