Trinity Biotech Plc
⚠️ Moderate Risk
FEI: 3002546385 • Bray, Wicklow • IRELAND
FEI Number
3002546385
Location
Bray, Wicklow
Country
IRELANDAddress
Ida Business Park, , Bray, Wicklow, Ireland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2021 | 82MZFTEST, HIV DETECTION | Division of Southwest Imports (DSWI) | |
| 2/4/2010 | 81KFFASSAY, HEPARIN | 479DV QUALITY | New York District Office (NYK-DO) |
| 2/4/2010 | 83LKTRESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA | 479DV QUALITY | New York District Office (NYK-DO) |
| 2/4/2010 | 75KQNRADIOASSAY, ANGIOTENSIN CONVERTING ENZYME | 479DV QUALITY | New York District Office (NYK-DO) |
| 8/12/2003 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/14/2003 | 81MTKKIT, SAMPLE COLLECTION, HIV | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Trinity Biotech Plc's FDA import refusal history?
Trinity Biotech Plc (FEI: 3002546385) has 6 FDA import refusal record(s) in our database, spanning from 3/14/2003 to 11/30/2021.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Trinity Biotech Plc's FEI number is 3002546385.
What types of violations has Trinity Biotech Plc received?
Trinity Biotech Plc has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Trinity Biotech Plc come from?
All FDA import refusal data for Trinity Biotech Plc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.