# FDA 483 - AEI Technologies, Inc - November 16, 2023

Source: https://www.globalkeysolutions.net/records/483/aei-technologies-inc/013f7217-1bb1-4a45-a4b5-3b7038f95f83

> FDA 483 for AEI Technologies, Inc on November 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AEI Technologies, Inc
- Inspection Date: 2023-11-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: AEI Technologies, Inc. in Bastrop, TX, a medical device manufacturer, was inspected and received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies in quality system documentation, including inadequate process and software validation, insufficient UDI labeling and GUDID registration, and poor record-keeping for nonconforming product rework, supplier management, and employee training. These issues indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2025-01-29](https://www.globalkeysolutions.net/records/483/aei-technologies-inc/52af80ff-42e8-4262-bb85-1cf1d95cc5dc)

## 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/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab