Almedica Europe Limited
⚠️ Moderate Risk
FEI: 3000208341 • Deeside, Clwyd • UNITED KINGDOM
FEI Number
3000208341
Location
Deeside, Clwyd
Country
UNITED KINGDOMAddress
Unit 107, Tenth Avenue, Deeside, Clwyd, 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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2005 | 63ACA07RISEDRONATE SODIUM (BONE CALCIUM REGULATOR) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/22/2005 | 60LCL99ANALGESIC, N.E.C. | New York District Office (NYK-DO) | |
| 6/1/2005 | 55PP53POLYETHYLENE GLYCOL 300 (PHARMACEUTIC NECESSITY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/3/2004 | 60MIP27NALMEFENE HYDROCHLORIDE (ANALGESIC, NARCOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/30/2004 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Almedica Europe Limited's FDA import refusal history?
Almedica Europe Limited (FEI: 3000208341) has 5 FDA import refusal record(s) in our database, spanning from 7/30/2004 to 11/3/2005.
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. Almedica Europe Limited's FEI number is 3000208341.
What types of violations has Almedica Europe Limited received?
Almedica Europe Limited 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 Almedica Europe Limited come from?
All FDA import refusal data for Almedica Europe Limited 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.