FDA Inspection
Primus Corporation dba Trinity BiotechPrimus Corporation dba Trinity Biotech – FDA Inspection, May 18, 2012
Record Details
This FDA Inspection record concerns Primus Corporation dba Trinity Biotech, with an inspection on May 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 18, 2012
- Product Type
- Devices
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ID · 4a899a6d-5863-4966-9591-11f669a03162
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783015
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.70(i)Validation of changes to automated process software
- 21 CFR 809.10(b)(5)(iv)Storage-instructions (no manipulation of reagent)
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Documentation of software validation
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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 | |
| September 6, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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