# Triangle Machine, Inc. – FDA 483, Apr 15, 2026

Source: https://www.keypedia.com/records/483/triangle-machine-inc/3f3300e3-face-414b-a0d3-84b53130b7ff

> FDA 483 for Triangle Machine, Inc. on April 15, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Triangle Machine, Inc.
- Inspection Date: 2026-04-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Triangle Machine, Inc. in South Bend, IN, a medical device manufacturer, received seven observations during an FDA inspection. The observations highlight significant deficiencies in the firm's quality management system, primarily concerning inadequate documentation and control procedures. These issues span risk management, supplier oversight, change control, production processes, design transfer, statistical techniques, and internal audits, indicating a need for comprehensive quality system improvements.

## Related Documents

- [483 - 2022-04-27](https://www.keypedia.com/records/483/triangle-machine-inc/caabda0a-53f2-47e2-af37-29f815f2f790) — date: April 27, 2022

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/triangle-machine-inc/21b285b2-6080-45a7-bfd1-200b96e2c741

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0