FDA 483 - Armbrust Inc. - September 25, 2025

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.