Lexamed, Ltd – FDA 483, Jul 9, 2026

An FDA inspection of Lexamed, Ltd in Toledo, OH, a contract laboratory, revealed significant deficiencies in laboratory controls and quality assurance. The firm failed to establish scientifically sound procedures for media preparation and sterility testing, leading to inconsistent and potentially unreliable results. Additionally, Lexamed did not thoroughly investigate microbial growth or visual anomalies in culture media and lacked defined hold times for sterilized equipment, raising concerns about product quality and safety.