FDA 483 - Tarry Medical Products, Inc. - October 09, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · f7789852-3d64-4419-b99b-a28ffe62e8d1