FDA Inspection
Trinity Biotech USATrinity Biotech USA – FDA Inspection, Sep 1, 2017
Record Details
This FDA Inspection record concerns Trinity Biotech USA, with an inspection on September 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f8350606-cca7-47e3-8bd6-678463ee3669
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024021
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trinity Biotech USA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Trinity Biotech USA
- FDA Inspection 865821 - 2014-02-07
- FDA Inspection 780448 - 2012-05-04
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