Vitalograph (Ireland), Ltd.
⚠️ High Risk
FEI: 3002808458 • Ennis • IRELAND
FEI Number
3002808458
Location
Ennis
Country
IRELANDAddress
Gort Road Business Park, , Ennis, , Ireland
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DEVICE GMP
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2023 | 73DQAOXIMETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/3/2019 | 73BZGSPIROMETER, DIAGNOSTIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 6/1/2012 | 73BZGSPIROMETER, DIAGNOSTIC | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 11/13/2006 | 73BZGSPIROMETER, DIAGNOSTIC | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 11/1/2004 | 73BZGSPIROMETER, DIAGNOSTIC | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/1/2004 | 73BZGSPIROMETER, DIAGNOSTIC | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/1/2004 | 73BZGSPIROMETER, DIAGNOSTIC | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/25/2004 | 73BZHMETER, PEAK FLOW, SPIROMETRY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/25/2004 | 73BZGSPIROMETER, DIAGNOSTIC | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/25/2004 | 73BZHMETER, PEAK FLOW, SPIROMETRY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 10/25/2004 | 73BZHMETER, PEAK FLOW, SPIROMETRY | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 5/18/2004 | 73BZGSPIROMETER, DIAGNOSTIC | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 4/9/2004 | 73BZGSPIROMETER, DIAGNOSTIC | 226DEVICE GMP | Southwest Import District Office (SWI-DO) |
| 4/9/2004 | 73BZGSPIROMETER, DIAGNOSTIC | 226DEVICE GMP | Southwest Import District Office (SWI-DO) |
| 4/9/2004 | 73BZGSPIROMETER, DIAGNOSTIC | Southwest Import District Office (SWI-DO) | |
| 4/9/2004 | 73BZGSPIROMETER, DIAGNOSTIC | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Vitalograph (Ireland), Ltd.'s FDA import refusal history?
Vitalograph (Ireland), Ltd. (FEI: 3002808458) has 16 FDA import refusal record(s) in our database, spanning from 4/9/2004 to 10/27/2023.
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. Vitalograph (Ireland), Ltd.'s FEI number is 3002808458.
What types of violations has Vitalograph (Ireland), Ltd. received?
Vitalograph (Ireland), Ltd. 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 Vitalograph (Ireland), Ltd. come from?
All FDA import refusal data for Vitalograph (Ireland), Ltd. 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.