# FDA 483 - Concert Medical, LLC - March 05, 2020

Source: https://www.keypedia.com/records/483/concert-medical-llc/e3696550-433f-4aa9-bdfe-642382aa5354

> FDA 483 for Concert Medical, LLC on March 05, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Concert Medical, LLC
- Inspection Date: 2020-03-05
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Concert Medical, LLC, a manufacturer of coronary guidewires in Norwell, MA, identified a significant quality system deficiency. The firm failed to adequately establish and follow procedures for controlling environmental conditions. Specifically, their SOP for timely completion of cleaning and maintenance logs in a controlled environment room was not followed during manufacturing.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maura-rooney/b9731b44-8033-4add-9863-545851b86bf7)
- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/concert-medical-llc/c7dc36c6-ce24-4928-af29-0c625f343d72

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