# FDA 483 - Cleartooth Electronics, Inc. - April 19, 2022

Source: https://www.keypedia.com/records/483/cleartooth-electronics-inc/2382d93b-4e11-49f7-a6f3-c115d746005d

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

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## Details

- Record Type: 483
- Company Name: Cleartooth Electronics, Inc.
- Inspection Date: 2022-04-19
- Product Type: device
- Office Name: FDA District Office — Denver, Colorado
- Summary: Cleartooth Electronics, Inc. in Boulder, CO, a medical device manufacturer, was inspected by the FDA from April 13-19, 2022. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design change, complaint handling, software validation, document control, and design transfer. These issues indicate a systemic lack of established and maintained quality system procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.keypedia.com/companies/cleartooth-electronics-inc/8a06a8c7-bde1-4ad5-8f96-a00486c23695

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0