FDA 483 - Tarry Medical Products, Inc. - October 09, 2025

Tarry Medical Products, Inc. in Danbury, CT, was cited for significant deficiencies in its quality control unit, particularly regarding product release, specification management, and validation. The inspection also revealed failures in utilizing stability testing data for product storage and expiration dating, and a lack of thorough investigation into numerous product complaints and batch discrepancies. These issues indicate a systemic breakdown in ensuring drug product quality and patient safety.