FDA 483 - BrittonField Laboratories Inc. - March 14, 2025

Brittonfield Laboratories Inc. in East Syracuse, NY, a contract testing laboratory, was inspected by the FDA. The inspection revealed a significant deficiency related to the routine checking and requalification of mechanical and electronic equipment, specifically incubators used for microbiological testing of drug products. This indicates a potential lack of assurance in the proper performance of critical equipment used for sterility and microbial count testing.