# FDA 483 - AEI Technologies, Inc - January 29, 2025

Source: https://www.globalkeysolutions.net/records/483/aei-technologies-inc/52af80ff-42e8-4262-bb85-1cf1d95cc5dc

> FDA 483 for AEI Technologies, Inc on January 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AEI Technologies, Inc
- Inspection Date: 2025-01-29
- Product Type: device
- Office Name: Dallas District Office
- Summary: AEI Technologies, Inc. in Bastrop, TX, was inspected and received a Form FDA 483 with three observations, two of which were repeats. The inspection revealed significant deficiencies in process validation for medical device test methods, inadequate documentation and timely closure of corrective and preventive actions (CAPAs), and poorly established procedures for handling rework of nonconforming products. These issues indicate a systemic breakdown in the firm's quality system.

## Related Documents

- [483 - 2023-11-16](https://www.globalkeysolutions.net/records/483/aei-technologies-inc/013f7217-1bb1-4a45-a4b5-3b7038f95f83)

## Related Officers

- [Katlin N. Stubbs](https://www.globalkeysolutions.net/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.globalkeysolutions.net/companies/aei-technologies-inc/d6894b07-62d8-42ec-938a-ab88924ca843

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