FDA 483 - Terumo Medical Corporation - October 28, 2022

Terumo Medical Corporation, a medical device manufacturer in Elkton, MD, received one observation during an FDA inspection. The observation highlighted that procedures for the review and disposition of nonconforming product were not adequately established. Specifically, the firm failed to document nonconforming material disposition in 13 out of 25 sampled records, indicating a lapse in quality system compliance.