# FDA 483 - Pro-Tech Design & Mfg. Inc. - June 27, 2025

Source: https://www.keypedia.com/records/483/pro-tech-design-mfg-inc/196562a4-d743-4cf7-9a4e-0c32baaeb4a6

> FDA 483 for Pro-Tech Design & Mfg. Inc. on June 27, 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: 2025-06-27
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Pro-Tech Design & Manufacturing, Inc. in Santa Fe Springs, CA, was inspected by the FDA from June 23-27, 2025. The inspection revealed a significant quality system deficiency concerning the lack of validation for the re-boxing process of sterile medical devices. This indicates a failure to ensure that processes whose results cannot be fully verified by subsequent inspection and test are properly validated.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/pro-tech-design-mfg-inc/48cb121e-511f-4b89-914b-507ccc03ef34

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b