# FDA 483 - Nu Dimension Tech Ventures, Llc - May 04, 2022

Source: https://www.globalkeysolutions.net/records/483/nu-dimension-tech-ventures-llc/c7223dba-b11a-44fb-a5c7-66608f9718a1

> FDA 483 for Nu Dimension Tech Ventures, Llc on May 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nu Dimension Tech Ventures, Llc
- Inspection Date: 2022-05-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Nu Dimension Tech Ventures, Llc, a medical device manufacturer in Huffman, TX, received a Form FDA 483 citing multiple quality system deficiencies. The inspection revealed inadequate procedures and documentation across several critical areas, including complaint handling, labeling, software validation, risk analysis, and design controls. A repeat observation was noted for the lack of review and approval of documents prior to issuance.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/nu-dimension-tech-ventures-llc/9d1a599e-a82d-4c24-a10a-0ba4fd729281

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab