Armbrust Inc.September 25, 2025

FDA 483 - Armbrust Inc. - September 25, 2025

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Record Details

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.

Company: Armbrust Inc.
Inspection Date: September 25, 2025
Product Type: Device
Office: Dallas District Office
Person: Elizabeth A. Krolczyk

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ID · 3a49e31b-200c-41fa-9972-8b36bc1f0047