FDA 483 - Teledyne Flir Commercial Systems, Inc. - October 04, 2022

Teledyne Flir Commercial Systems, Inc. in Nashua, NH, was inspected from October 3-4, 2022, and received a Form 483 with two observations. The inspection revealed inadequate procedures for servicing activities, including a lack of review for potential complaints and medical device reportability, and failure to maintain adequate complaint files. Additionally, the firm did not consistently document test and inspection data for serviced devices or include Unique Device Identifiers (UDI) in relevant procedures.