# FDA 483 - ReNovo, Inc. - May 18, 2023

Source: https://www.keypedia.com/records/483/renovo-inc/0e00a46a-3504-49d1-9e3f-4eef6e08e535

> FDA 483 for ReNovo, Inc. on May 18, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ReNovo, Inc.
- Inspection Date: 2023-05-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Renovo, Inc. in Bend, OR, was inspected by the FDA and received a Form FDA 483 with three observations. The inspection revealed deficiencies in establishing adequate procedures for controlling environmental conditions, managing non-conforming products, and ensuring adherence to equipment maintenance schedules for medical devices. These issues indicate potential quality system failures that could impact product quality and safety.

## Related Documents

- [483 - 2018-06-18](https://www.keypedia.com/records/483/renovo-inc/92483553-8d9d-4e91-b4cf-db00447ee0be)
- [WARNING_LETTER - 2023-05-18](https://www.keypedia.com/records/warning_letter/renovo-inc/eba994c2-de71-4155-9f8a-a216ffda9c3b)

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/renovo-inc/05b78813-dfe4-488e-b1f9-624731d7205d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822