# FDA 483 - BioVision Technologies, LLC - December 16, 2021

Source: https://www.keypedia.com/records/483/biovision-technologies-llc/e7d6dec6-9130-4889-8c15-e678f935c3fe

> FDA 483 for BioVision Technologies, LLC on December 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioVision Technologies, LLC
- Inspection Date: 2021-12-16
- Product Type: device
- Office Name: Denver District Office
- Summary: BioVision Technologies, LLC, a medical device manufacturer in Boulder, CO, received an FDA Form 483 citing significant quality system deficiencies. The inspection revealed inadequate process control procedures for sterile devices, insufficient acceptance activity procedures, and failures in equipment calibration and maintenance. Additionally, the firm's device history records did not adequately demonstrate manufacturing in accordance with device master records.

## Related Officers

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

Company: https://www.keypedia.com/companies/biovision-technologies-llc/ee972796-a4b7-49b6-a52e-11b537c87aa8

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