# FDA 483 - VITANG TECHNOLOGY LLC - December 08, 2023

Source: https://www.globalkeysolutions.net/records/483/vitang-technology-llc/21472085-4bd3-4815-8d6c-072bec5130f8

> FDA 483 for VITANG TECHNOLOGY LLC on December 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VITANG TECHNOLOGY LLC
- Inspection Date: 2023-12-08
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: VITANG TECHNOLOGY LLC in Tustin, CA, was inspected by the FDA, resulting in 11 observations, many of which are repeat findings from a previous inspection. The inspection revealed significant deficiencies across multiple quality system areas, including complaint handling, software validation, supplier management, CAPA procedures, equipment qualification, device history records, incoming product acceptance, UDI labeling, quality audits, management review, and personnel training. The firm appears to have a severely underdeveloped or non-compliant quality system, indicating a high level of non-compliance.

## Related Documents

- [483 - 2023-01-31](https://www.globalkeysolutions.net/records/483/vitang-technology-llc/2bfb650a-307a-44bf-86a9-885cf7239e8e)
- [WARNING_LETTER - 2023-01-31](https://www.globalkeysolutions.net/records/warning_letter/vitang-technology-llc/5be43dc4-edea-4e59-be3c-9af5953579cd)

## 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