FDA 483 - TAMA Research Corporation - April 22, 2019

TAML Research Corporation, a medical device manufacturer in Phoenix, AZ, was cited with three observations during an FDA inspection. The firm lacked established procedures for Medical Device Reporting (MDR) and device history records, specifically regarding software versions and Unique Device Identifiers (UDI) for their products. These issues indicate deficiencies in their quality system for device tracking and adverse event reporting.