# FDA 483 - UIH Technologies LLC - August 20, 2025

Source: https://www.globalkeysolutions.net/records/483/uih-technologies-llc/a3ba6644-3975-4deb-aa03-26cd618628e7

> FDA 483 for UIH Technologies LLC on August 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UIH Technologies LLC
- Inspection Date: 2025-08-20
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of UIH Technologies LLC, a medical device contract manufacturer in Houston, TX, revealed three significant observations. These included deficiencies in medical device labeling regarding Unique Device Identifiers (UDI), inadequate procedures for receiving and evaluating complaints, and insufficient establishment of finished device acceptance procedures. These findings indicate issues within the firm's quality system.

## Related Documents

- [483 - 2025-08-20](https://www.globalkeysolutions.net/records/483/uih-technologies-llc/0a52840d-9652-406d-acd4-4da0b4a92263)

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/uih-technologies-llc/77833ab3-177f-4a47-b6ed-771b0a290c4e

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9