# FDA 483 - Texas Medical Technology Inc. - March 03, 2022

Source: https://www.globalkeysolutions.net/records/483/texas-medical-technology-inc/c27d14aa-19f9-4d1d-9c36-e17025a6e9f2

> FDA 483 for Texas Medical Technology Inc. on March 03, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Texas Medical Technology Inc.
- Inspection Date: 2022-03-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Texas Medical Technology Inc. in Houston, TX, revealed numerous deficiencies in their quality system for manufacturing surgical gowns. The firm lacked adequate procedures for vendor qualification, process validation, device master records, device history records, process controls, statistical techniques, labeling, corrective/preventive actions, and medical device reporting. These findings indicate significant non-compliance with regulatory requirements for medical device manufacturing.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/texas-medical-technology-inc/c2c6a977-79e9-4bf4-923d-e932e35869c1

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