FDA 483 - Hoosier, Inc - August 21, 2025

Hoosier, Inc., a contract manufacturer of surgical implantable devices in Corona, CA, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily concern inadequate validation of equipment, insufficient supplier and customer agreements, and deficiencies in CAPA, complaint handling, and incoming material acceptance procedures. These issues indicate a lack of robust control over critical manufacturing and quality processes.