FDA Inspection 1273409 — Triangle Manufacturing Co. Inc.
The FDA completed an inspection of Triangle Manufacturing Co. Inc. on June 12, 2025 in Upper Saddle River, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 12, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Upper Saddle River, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |