FDA 483 - ATZ Manufacturing - July 24, 2025
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ATZ Manufacturing in Marshall, MN, a manufacturer of Class II powered wheelchairs, was cited for significant quality system deficiencies. The firm failed to establish and implement a comprehensive quality system, including procedures for production, purchasing, training, UDI, CAPA, device history records, complaint handling, and servicing, since acquiring the company in January 2022. These widespread issues indicate a severe lack of control over the manufacturing and post-market processes for their medical devices.
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ID · 8a98736a-ccc2-46ff-8d2c-b4b2b49e8f66