Pharmacy2u
⚠️ Moderate Risk
FEI: 3006347265 • Leedsleeds • UNITED KINGDOM
FEI Number
3006347265
Location
Leedsleeds
Country
UNITED KINGDOMAddress
1, Hawthorn Parkcoal Road, , Leedsleeds, , 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).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/14/2010 | 61TAA17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/3/2008 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 6/17/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/28/2007 | 53BH01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 488HEALTH C | Philadelphia District Office (PHI-DO) |
| 11/28/2007 | 56YBK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/1/2007 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 7/23/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pharmacy2u's FDA import refusal history?
Pharmacy2u (FEI: 3006347265) has 7 FDA import refusal record(s) in our database, spanning from 7/23/2007 to 7/14/2010.
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. Pharmacy2u's FEI number is 3006347265.
What types of violations has Pharmacy2u received?
Pharmacy2u 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 Pharmacy2u come from?
All FDA import refusal data for Pharmacy2u 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.