# FDA 483 - Refine USA, LLC - August 16, 2023

Source: https://www.keypedia.com/records/483/refine-usa-llc/028708dd-020f-4e4f-a32b-45868dd37779

> FDA 483 for Refine USA, LLC on August 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Refine USA, LLC
- Inspection Date: 2023-08-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Refine USA, LLC, a specification developer in Jacksonville, FL, was cited for inadequate purchasing controls during an FDA inspection. The firm failed to ensure that purchased products and services conform to specified requirements. This was evidenced by a contract manufacturer making an unapproved change to the Class II "Rejuvpen NXT" device without notifying Refine USA, LLC, affecting an estimated (b)(4) units.

## Related Officers

- [Alex J. Wild](https://www.keypedia.com/people/alex-j-wild/bb1b66b3-19b9-480e-af0b-f06f8de0d930)

Company: https://www.keypedia.com/companies/refine-usa-llc/52f6174e-99ed-4128-9380-d6434537b084

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6