Athlone Ballymurray Co
⚠️ High Risk
FEI: 3007558429 • Roscommon, Co. ROSCOMMON • IRELAND
FEI Number
3007558429
Location
Roscommon, Co. ROSCOMMON
Country
IRELANDAddress
Ballymurry National School, , Roscommon, Co. ROSCOMMON, 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
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 |
|---|---|---|---|
| 3/23/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56ACK20PENICILLIN V, NATURAL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56ACK20PENICILLIN V, NATURAL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Athlone Ballymurray Co's FDA import refusal history?
Athlone Ballymurray Co (FEI: 3007558429) has 8 FDA import refusal record(s) in our database, spanning from 3/23/2017 to 3/23/2017.
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. Athlone Ballymurray Co's FEI number is 3007558429.
What types of violations has Athlone Ballymurray Co received?
Athlone Ballymurray Co has been cited for 1 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 Athlone Ballymurray Co come from?
All FDA import refusal data for Athlone Ballymurray Co 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.