FDA 483 - Bennett Testing Service, Inc. - June 09, 2025

An FDA inspection of Bennett Testing Service, Inc. in Rahway, NJ, a control testing laboratory, revealed significant deficiencies in their quality control systems. Observations included incomplete equipment qualification, lack of method verification for USP methods, and inadequate written procedures for critical GMP topics such as data backup, audit trail review, CAPA, and OOS investigations. These issues indicate a systemic failure to ensure data integrity and product quality.