# FDA 483 - Zuga Medical Inc. - June 26, 2023

Source: https://www.globalkeysolutions.net/records/483/zuga-medical-inc/98ef4c93-80c1-4291-b2be-300c5afb6a8d

> FDA 483 for Zuga Medical Inc. on June 26, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Zuga Medical Inc.
- Inspection Date: 2023-06-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Zuga Medical Inc., a medical device manufacturer in Auborn Township, OH, was inspected by the FDA from June 12-26, 2023. The inspection revealed significant deficiencies in quality system procedures, including failures in complaint handling, acceptance activities documentation, quality audits, and design transfer processes. These issues indicate a lack of adequate controls for ensuring the quality and safety of their dental devices, particularly those sold in the Chinese market.

## Related Documents

- [483 - 2022-04-12](https://www.globalkeysolutions.net/records/483/zuga-medical-inc/be50069b-656c-4234-a24c-cb6128800204)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/zuga-medical-inc/f87fa18d-c057-4f61-b53d-cee5ad70a9ce

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22