Durbin Plc
⚠️ Moderate Risk
FEI: 3003791221 • Harrow, Middlesex • UNITED KINGDOM
FEI Number
3003791221
Location
Harrow, Middlesex
Country
UNITED KINGDOMAddress
180 Northolt Road, , Harrow, Middlesex, United Kingdom
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
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).
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2013 | 66SCB27NIFEDIPINE (VASODILATOR) | New York District Office (NYK-DO) | |
| 5/17/2013 | 62VCS99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 5/17/2013 | 62VCS99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 5/17/2013 | 62VCS99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 3/5/2013 | 61KIA22GLYCOPYRROLATE (ANTI-CHOLINERGIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 11/6/2012 | 85HHFREMOVER, INTRAUTERINE DEVICE, CONTRACEPTIVE, HOOK-TYPE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/7/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/11/2007 | 56YCK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/14/2007 | 65VCB40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Durbin Plc's FDA import refusal history?
Durbin Plc (FEI: 3003791221) has 9 FDA import refusal record(s) in our database, spanning from 2/14/2007 to 8/13/2013.
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. Durbin Plc's FEI number is 3003791221.
What types of violations has Durbin Plc received?
Durbin Plc has been cited for 3 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 Durbin Plc come from?
All FDA import refusal data for Durbin 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.