FDA 483 - TAMA Research Corporation - October 05, 2023

TAMA Research Corporation, a medical device manufacturer in Scottsdale, AZ, was inspected by the FDA from October 3-5, 2023. The inspection revealed two significant issues: a failure to provide required Unique Device Identification (UDI) information for their TAMA BlueOnyx Pro device to the Global UDI Database, and inadequate record-keeping for complaint investigations. These findings indicate deficiencies in device identification and quality system processes.