FDA 483 - Indiana Coast Medical LLC - April 02, 2025

Indiana Coast Medical LLC, an HCT/P distributor in Valparaiso, IN, was cited for significant deficiencies in its operations. The inspection revealed a lack of established procedures for HCT/P manufacturing, storage, and distribution, as well as failures in evaluating incoming products for contamination. Additionally, the firm's storage areas were not adequately controlled to prevent mix-ups or improper release of HCT/Ps.