Company
United StatesTrinity Biotech USA, Jamestown, NY – FDA Inspections
Inspection records and compliance data for Trinity Biotech USA in Jamestown, New York. 3 FDA inspections on record, 1 Form 483, last inspected September 01, 2017.
Company Profile
This profile covers Trinity Biotech USA based in Jamestown, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected May 4, 2012. Last inspected September 1, 2017.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
- Report of risk to health1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 1, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1024021 |
| February 7, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 865821 |
| May 4, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 780448 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Trinity Biotech USA
FEI Number
1318354
Address
2823 Girts Rd, Jamestown, New York 14701, United States
Country
United States
ID: 84422892-686f-47c7-a656-eab43686e40f