FDA Inspection
Primus Corporation dba Trinity BiotechPrimus Corporation dba Trinity Biotech – FDA Inspection, Feb 6, 2020
Record Details
This FDA Inspection record concerns Primus Corporation dba Trinity Biotech, with an inspection on February 6, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 6, 2020
- Product Type
- Devices
View Company Profile
ID · 71d6359a-ee57-4657-a7d4-c107d5cd5302
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1117396
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 806.20(a)Records not kept
Full citation text and observation details available on the Dashboard.
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 |
| September 5, 2019 | Not classified | Kansas City District Office | |
| September 6, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Primus Corporation dba Trinity Biotech
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.