FDA 483 - Cade Medical, Inc. - March 06, 2019

Cade Medical, Inc. in Honolulu, HI, an HCT/P distributor, was cited for significant deficiencies in record-keeping and temperature control during an FDA inspection. Observations included incomplete and missing records for various processes, unrecorded storage temperatures for human tissues, and a lack of periodic review of recorded temperatures to ensure compliance. These issues indicate a failure to maintain adequate control over critical aspects of HCT/P handling and storage.