FDA Inspection
Trigon America LLCTrigon America LLC – FDA Inspection, Feb 13, 2019
Record Details
This FDA Inspection record concerns Trigon America LLC, with an inspection on February 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b720bd10-2465-47e2-9e26-92eae4d2b57c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079276
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Trigon America LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 16, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Trigon America LLC
- FDA Inspection 1264962 - 2025-02-27
- FDA Inspection 976426 - 2016-05-16
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