# FDA 483 - VITANG TECHNOLOGY LLC - January 31, 2023

Source: https://www.globalkeysolutions.net/records/483/vitang-technology-llc/2bfb650a-307a-44bf-86a9-885cf7239e8e

> FDA 483 for VITANG TECHNOLOGY LLC on January 31, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: VITANG TECHNOLOGY LLC
- Inspection Date: 2023-01-31
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: VITANG TECHNOLOGY LLC, a manufacturer and specification developer of UniSmile Clear Aligners in Tustin, CA, was cited for numerous significant quality system deficiencies. The inspection revealed issues across design control, software validation, complaint handling, supplier management, equipment qualification and calibration, device history records, quality audits, management reviews, and personnel training. These observations indicate a broad lack of established and followed procedures essential for medical device manufacturing.

## Related Documents

- [WARNING_LETTER - 2023-01-31](https://www.globalkeysolutions.net/records/warning_letter/vitang-technology-llc/5be43dc4-edea-4e59-be3c-9af5953579cd)
- [483 - 2023-12-08](https://www.globalkeysolutions.net/records/483/vitang-technology-llc/21472085-4bd3-4815-8d6c-072bec5130f8)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.globalkeysolutions.net/companies/vitang-technology-llc/74e76d40-058c-4e23-b7fb-47c2ab641764

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6