FDA Inspection 1313224 — Triangle Machine, Inc.
The FDA completed an inspection of Triangle Machine, Inc. on April 15, 2026 in South Bend, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- South Bend, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23023 | ISO 13485:2016 Clause 4.1.4 | Changes to the QMS not adequately controlled or evaluated |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23127 | ISO 13485:2016 Clause 7.3.8 | Design and development transfer procedures not documented |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23209 | ISO 13485:2016 Clause 8.1 | Methods for monitoring, measurement, analysis, and improvement not determined |
| 23223 | ISO 13485:2016 Clause 8.2.4 | Internal audit criteria, scope, interval, and methods not defined and recorded |