# FDA 483 - PRO-TECH Design & Mfg., Inc. - April 14, 2025

Source: https://www.keypedia.com/records/483/pro-tech-design-mfg-inc/623ff002-4125-4ae1-b2af-cc9a05d95b7d

> FDA 483 for PRO-TECH Design & Mfg., Inc. on April 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PRO-TECH Design & Mfg., Inc.
- Inspection Date: 2025-04-14
- Product Type: device
- Office Name: Dallas District Office
- Summary: PRO-TECH Design & Mfg., Inc. in Arlington, TX, was inspected by the FDA from April 10-14, 2025. The inspection revealed a significant issue regarding the lack of documentation for major equipment used in a validated process. Specifically, the firm failed to validate its burst strength testing process and the associated Burst Strength Tester, which has been in use since 2012 for testing packaging seals.

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/pro-tech-design-mfg-inc/f84ae588-49bd-4504-af30-a1818fd1927e

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