# FDA 483 - Armbrust Inc. - September 25, 2025

Source: https://www.keypedia.com/records/483/armbrust-inc/3a49e31b-200c-41fa-9972-8b36bc1f0047

> FDA 483 for Armbrust Inc. on September 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Armbrust Inc.
- Inspection Date: 2025-09-25
- Product Type: device
- Office Name: Dallas District Office
- Summary: Armbrust Inc., a manufacturer in Elgin, TX, received a Form FDA-483 with two observations during an inspection from 9/22/2025 to 9/25/2025. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the performance of internal quality audits and the control of nonconforming products. These issues indicate a lack of adherence to established procedures and proper documentation practices.

## Related Officers

- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/armbrust-inc/f263766f-e1aa-4c00-a45b-dec742bf1567

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