FDA 483 - Cade Medical, Inc. - September 18, 2019

Cade Medical, Inc., an HCT/Ps storage and distributor in Temecula, CA, was cited for deficiencies in its record-keeping practices. The inspection revealed that records for the receipt, distribution, and temperature monitoring of tissue products consistently failed to identify the individuals performing these critical activities. This lack of personnel identification resulted in incomplete historical documentation for various operational processes.