HEALTH PHARM LEICESTER LIMITED
⚠️ Moderate Risk
FEI: 3015557888 • Leicester, LCE • UNITED KINGDOM
FEI Number
3015557888
Location
Leicester, LCE
Country
UNITED KINGDOMAddress
Units, 3 Victoria Parade, Leicester, LCE, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 12/26/2019 | 61MAB11MAGNESIUM SULFATE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2019 | 79LRRKIT, FIRST AID | Division of Northern Border Imports (DNBI) | |
| 12/11/2019 | 98NCA07NICOTINE LOZENGE/DISSOLVABLE | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HEALTH PHARM LEICESTER LIMITED's FDA import refusal history?
HEALTH PHARM LEICESTER LIMITED (FEI: 3015557888) has 3 FDA import refusal record(s) in our database, spanning from 12/11/2019 to 12/26/2019.
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. HEALTH PHARM LEICESTER LIMITED's FEI number is 3015557888.
What types of violations has HEALTH PHARM LEICESTER LIMITED received?
HEALTH PHARM LEICESTER 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 HEALTH PHARM LEICESTER LIMITED come from?
All FDA import refusal data for HEALTH PHARM LEICESTER 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.