Company
United StatesPrimus Corporation dba Trinity Biotech, Kansas City, MO – FDA Inspections
Inspection records and compliance data for Primus Corporation dba Trinity Biotech in Kansas City, Missouri. 8 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected September 26, 2022.
Company Profile
This profile covers Primus Corporation dba Trinity Biotech based in Kansas City, Missouri, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 2
- VAI
- 1
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected April 15, 2009. Last inspected September 26, 2022.
Most cited issue areas
- Design history file1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Documentation of software validation1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1180790 |
| September 17, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1154252 |
| February 6, 2020 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1117396 |
| September 5, 2019 | Not classified | Medical Devices & Rad Health | 1122890 |
| September 6, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1064644 |
| January 30, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 912071 |
| May 18, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 783015 |
| April 15, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 578776 |
FDA documents
Form 483s (1)
Warning Letters (1)
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Company Information
Name
Primus Corporation dba Trinity Biotech
FEI Number
1931251
Address
4231 E 75th Ter, Kansas City, Missouri 64132, United States
Country
United States
ID: df325fd3-9d48-441b-a9f5-54b8401243c5