# FDA 483 - AlloSource - July 27, 2022

Source: https://www.keypedia.com/records/483/allosource/3eedc828-9999-4064-bd21-a17a742df88e

> FDA 483 for AlloSource on July 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AlloSource
- Inspection Date: 2022-07-27
- Product Type: device
- Office Name: Denver District Office
- Summary: AlloSource, Inc. in Centennial, CO, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately document equipment calibration, specifically pull test results for tray sealers used in sterile packaging. Additionally, product labeling for ReConnex™ Pre-Sutured Tendon devices lacked a human-readable Unique Device Identifier (UDI) as required by regulations.

## Related Documents

- [483 - 2023-03-30](https://www.keypedia.com/records/483/allosource/1db928f1-d988-4de3-9463-71ef1b113f4b)

## Related Officers

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

Company: https://www.keypedia.com/companies/allosource/561511d2-2b9d-4a29-9565-deccb49a8455

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