FDA Inspection
Trinity Biotech USATrinity Biotech USA – FDA Inspection, May 4, 2012
Record Details
This FDA Inspection record concerns Trinity Biotech USA, with an inspection on May 4, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trinity Biotech USA
- Inspection Date
- May 4, 2012
- Product Type
- Devices
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ID · 86cbb93a-5a50-4224-8589-2a7b6fe51b48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780448
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Trinity Biotech USA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Trinity Biotech USA
- FDA Inspection 1024021 - 2017-09-01
- FDA Inspection 865821 - 2014-02-07
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