FDA Inspection
Primus Corporation dba Trinity BiotechPrimus Corporation dba Trinity Biotech – FDA Inspection, Sep 6, 2018
Record Details
This FDA Inspection record concerns Primus Corporation dba Trinity Biotech, with an inspection on September 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 77932d7e-eec1-47f3-b4e1-cfcdfd4e8ca1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1064644
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.184Lack of or inadequate DHR procedures
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Other FDA inspections of Primus Corporation dba Trinity Biotech
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 17, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 6, 2020 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 5, 2019 | Not classified | Kansas City District Office | |
| January 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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