TAMA Research CorporationApril 22, 2019

FDA 483 - TAMA Research Corporation - April 22, 2019

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Record Details

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.

Company: TAMA Research Corporation
Inspection Date: April 22, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Kwong P. Lee (investigator)

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ID · c174024e-1729-4640-975e-9afc95fb587d