# FDA 483 - QBTech Inc. - May 23, 2024

Source: https://www.globalkeysolutions.net/records/483/qbtech-inc/4cc268fd-36e7-4db6-bee0-dc427a199681

> FDA 483 for QBTech Inc. on May 23, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: QBTech Inc.
- Inspection Date: 2024-05-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: QBTech Inc., a medical device manufacturer in Houston, TX, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate recall documentation, UDI non-compliance, issues with device master records, and unvalidated software. These findings indicate a need for comprehensive improvements in the firm's quality management system.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/qbtech-inc/cd6ee3ee-1405-4a06-89fa-25368acadaf3

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