FDA 483 - Tarry Medical Products, Inc. - March 03, 2026

An FDA inspection of Tarry Medical Products, Inc. in Danbury, CT, a manufacturer of Class II medical devices, revealed significant deficiencies in their purchasing control procedures. The firm failed to adequately monitor supplier performance for temperature probes, leading to unauthorized changes by a contract manufacturer and unaddressed non-fulfillment of purchasing requirements. These issues indicate a moderate severity of non-compliance with quality system regulations.