FDA 483 - Tri-anim Health Services, Inc. - August 21, 2025

Tri-anim Health Services, Inc. in Dublin, OH, a medical device specification developer, was inspected by the FDA from August 18-21, 2025. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for supplier management, corrective and preventive actions, risk analysis, design verification, and internal quality audits. These findings indicate a broad lack of robust quality system controls for medical device development.