# FDA 483 - Rhausler Inc - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/rhausler-inc/b46dc4fe-b346-4e67-9b10-9ca1e7dd721e

> FDA 483 for Rhausler Inc on December 20, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rhausler Inc
- Inspection Date: 2024-12-20
- Product Type: device
- Office Name: San Francisco District Office
- Summary: Rhausler Inc. in Fremont, CA, was inspected regarding its manufacturing of the Class 2 Rhausler Cervical Vertebrae Plating System. The inspection revealed significant deficiencies across its quality management system, including failures in procedure establishment, CAPA documentation, complaint handling, internal audits, management review documentation, and personnel training. These issues indicate a systemic lack of adherence to quality system requirements.

## Related Officers

- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.globalkeysolutions.net/companies/rhausler-inc/ebf838cb-e931-4e17-a4c1-795cecdc721e

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df