# FDA 483 - ReNovo, Inc. - June 18, 2018

Source: https://www.globalkeysolutions.net/records/483/renovo-inc/92483553-8d9d-4e91-b4cf-db00447ee0be

> FDA 483 for ReNovo, Inc. on June 18, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ReNovo, Inc.
- Inspection Date: 2018-06-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: ReNovo, Inc., a reprocessor in Bend, OR, was cited for deficiencies related to its supplier and contractor management. The inspection revealed inadequate documentation for the evaluation and approval of contractors, as well as a lack of formal agreements requiring suppliers to notify the firm of product or service changes. These issues indicate weaknesses in the firm's quality system regarding external party controls.

## Related Documents

- [483 - 2023-05-18](https://www.globalkeysolutions.net/records/483/renovo-inc/0e00a46a-3504-49d1-9e3f-4eef6e08e535)
- [WARNING_LETTER - 2023-05-18](https://www.globalkeysolutions.net/records/warning_letter/renovo-inc/eba994c2-de71-4155-9f8a-a216ffda9c3b)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)

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

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