# FDA 483 - ATZ Manufacturing - July 24, 2025

Source: https://www.keypedia.com/records/483/atz-manufacturing/8a98736a-ccc2-46ff-8d2c-b4b2b49e8f66

> FDA 483 for ATZ Manufacturing on July 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ATZ Manufacturing
- Inspection Date: 2025-07-24
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/atz-manufacturing/c199711c-1a04-41bd-9d5e-cfbc9ebfa731

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d