# FDA 483 - Northgate Technologies, Inc. - April 19, 2022

Source: https://www.globalkeysolutions.net/records/483/northgate-technologies-inc/f9e962af-f05e-47b4-8e3d-5969a57b32f1

> FDA 483 for Northgate Technologies, Inc. on April 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northgate Technologies, Inc.
- Inspection Date: 2022-04-19
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Northgate Technologies, Inc. in Elgin, IL, a medical device manufacturer, identified one observation. The firm failed to adequately establish procedures for servicing activities and verifying that servicing meets specified requirements. This included allowing an unqualified customer in Japan to perform servicing and repairs on their Class 2 Nebulae I System.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amanda-dinaro/6df79979-ad5c-46f5-8917-197f8a0870e0)

Company: https://www.globalkeysolutions.net/companies/northgate-technologies-inc/97add538-0dfe-475c-a4d7-177331742fb0

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669