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

Source: https://www.keypedia.com/records/483/teledyne-flir-commercial-systems-inc/4c81c823-2e0a-4aeb-a59b-0dc55e5ce385

> FDA 483 for Teledyne Flir Commercial Systems, Inc. on October 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teledyne Flir Commercial Systems, Inc.
- Inspection Date: 2022-10-04
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.keypedia.com/companies/teledyne-flir-commercial-systems-inc/1f84d8af-18df-472d-914c-89b4c17ad269

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94