# FDA 483 - Tensentric, LLC - April 14, 2023

Source: https://www.keypedia.com/records/483/tensentric-llc/2b5d6431-2463-4d4c-b208-0c167b1e9b1f

> FDA 483 for Tensentric, LLC on April 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tensentric, LLC
- Inspection Date: 2023-04-14
- Product Type: device
- Office Name: Denver District Office
- Summary: Tensentric, LLC, a contract manufacturer in Louisville, CO, was inspected by the FDA from April 11-14, 2023. The inspection revealed significant deficiencies in the company's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and follow procedures for effectiveness checks, documentation, and the handling of ineffective CAPAs.

## Related Officers

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

Company: https://www.keypedia.com/companies/tensentric-llc/05ff7a04-9d94-428d-8455-333aa23546d0

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