FDA 483 - SILLIKER INC - April 25, 2024

Merieux NutriSciences, a contract laboratory in Gainesville, FL, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed failures in thoroughly investigating discrepancies and out-of-specification results, inadequate laboratory controls including method suitability and media testing, and a lack of proper data integrity controls for electronic systems. Additionally, the firm lacked written procedures for its quality control unit and failed to provide adequate cGMP training records for its laboratory personnel.