# FDA 483 - Colorado Therapeutics LLC - August 21, 2019

Source: https://www.globalkeysolutions.net/records/483/colorado-therapeutics-llc/e6f55554-709b-4669-bc49-3e2e24e7a464

> FDA 483 for Colorado Therapeutics LLC on August 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Colorado Therapeutics LLC
- Inspection Date: 2019-08-21
- Product Type: device
- Office Name: Denver District Office
- Summary: Colorado Therapeutics LLC, a medical device manufacturer in Louisville, CO, was cited for deficiencies in its quality system. The inspection revealed that procedures for device history records were not adequately established, leading to issues with tracking and accounting for finished goods and samples. This indicates a lack of robust manufacturing control and record-keeping practices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/colorado-therapeutics-llc/15e52592-00dc-4516-932d-f33489a05524

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