Norton Healthcare Limited
⚠️ High Risk
FEI: 3003925187 • Runcorn, Cheshire • UNITED KINGDOM
FEI Number
3003925187
Location
Runcorn, Cheshire
Country
UNITED KINGDOMAddress
Whitehouse Vale Ind. Estate, Preston Brook, Aston Lane North, Runcorn, Cheshire, United Kingdom
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).
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 |
|---|---|---|---|
| 12/27/2024 | 64TCK02GLATIRAMER ACETATE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2014 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/12/2008 | 61NDC83ESCITALOPRAM OXALATE | 342PERSONALRX | New York District Office (NYK-DO) |
| 2/14/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Norton Healthcare Limited's FDA import refusal history?
Norton Healthcare Limited (FEI: 3003925187) has 4 FDA import refusal record(s) in our database, spanning from 2/14/2002 to 12/27/2024.
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. Norton Healthcare Limited's FEI number is 3003925187.
What types of violations has Norton Healthcare Limited received?
Norton Healthcare 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 Norton Healthcare Limited come from?
All FDA import refusal data for Norton Healthcare 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.