# FDA 483 - Dechoker, LLC - September 15, 2021

Source: https://www.keypedia.com/records/483/dechoker-llc/e6b4aa49-8d1a-495a-be45-6ce2dd977910

> FDA 483 for Dechoker, LLC on September 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dechoker, LLC
- Inspection Date: 2021-09-15
- Product Type: device
- Office Name: Denver District Office
- Summary: DeChoker LLC, a medical device manufacturer in Wheat Ridge, CO, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate complaint handling procedures, insufficient purchasing controls for third-party services, and a lack of validation for quality system software. These issues indicate a failure to maintain adequate controls over product quality and regulatory compliance.

## Related Documents

- [483 - 2021-02-26](https://www.keypedia.com/records/483/dechoker-llc/4897bb94-bd5a-4255-909f-92ef623f2105)

## Related Officers

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

Company: https://www.keypedia.com/companies/dechoker-llc/5be77f8c-ae26-4b7e-90dc-3a7e38850854

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face