McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory
⚠️ High Risk
FEI: 3011420468 • Baldoyle Dublin 13, Co. DUBLIN • IRELAND
FEI Number
3011420468
Location
Baldoyle Dublin 13, Co. DUBLIN
Country
IRELANDAddress
Unit 25 Grange Parade, Baldoyle Industrial Estate, Baldoyle Dublin 13, Co. DUBLIN, 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 |
|---|---|---|---|
| 7/18/2023 | 62OCC41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2021 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory's FDA import refusal history?
McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory (FEI: 3011420468) has 3 FDA import refusal record(s) in our database, spanning from 3/23/2017 to 7/18/2023.
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. McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory's FEI number is 3011420468.
What types of violations has McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory received?
McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory 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 McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory come from?
All FDA import refusal data for McDermott Laboratories Ltd. trading as Mylan Dublin Respiratory 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.