Amo Ireland
⚠️ Moderate Risk
FEI: 3008602765 • Quarryvale • IRELAND
FEI Number
3008602765
Location
Quarryvale
Country
IRELANDAddress
Block B Liffey Valley Campus, , Quarryvale, , 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
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).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/1/2024 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 11/1/2024 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 2/15/2024 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | Division of Southeast Imports (DSEI) | |
| 5/11/2023 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 5/10/2023 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Amo Ireland's FDA import refusal history?
Amo Ireland (FEI: 3008602765) has 5 FDA import refusal record(s) in our database, spanning from 5/10/2023 to 11/1/2024.
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. Amo Ireland's FEI number is 3008602765.
What types of violations has Amo Ireland received?
Amo Ireland has been cited for 6 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 Amo Ireland come from?
All FDA import refusal data for Amo Ireland 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.