FDA 483 - Neogen Corporation - March 16, 2021

Neogen Corporation, an animal drug manufacturer in Lexington, KY, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate laboratory record-keeping and data integrity controls, improper storage conditions for drug products, failure to follow stability testing programs, and insufficient control over label and labeling material access and destruction of obsolete materials. These issues indicate significant concerns regarding quality control and adherence to good manufacturing practices.