FDA 483 - Medsource, Inc. - March 31, 2015

Medsource, Inc. in Tiverton, RI, a manufacturer of HCT/Ps and medical devices, was cited for significant deficiencies across its operations. The inspection revealed a lack of critical procedures for HCT/P handling, medical device storage, and fundamental quality system elements. These issues indicate a severely underdeveloped quality management system.