Sauflon Pharmaceuticals Limited
⚠️ Moderate Risk
FEI: 3002982796 • Twickenham • UNITED KINGDOM
FEI Number
3002982796
Location
Twickenham
Country
UNITED KINGDOMAddress
49-53 York Street, MIDDLESEX, Twickenham, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/18/2017 | 86LRXCASE, CONTACT LENS | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 4/22/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 2/5/2009 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 341REGISTERED | New York District Office (NYK-DO) |
| 2/19/2004 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Sauflon Pharmaceuticals Limited's FDA import refusal history?
Sauflon Pharmaceuticals Limited (FEI: 3002982796) has 4 FDA import refusal record(s) in our database, spanning from 2/19/2004 to 10/18/2017.
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. Sauflon Pharmaceuticals Limited's FEI number is 3002982796.
What types of violations has Sauflon Pharmaceuticals Limited received?
Sauflon Pharmaceuticals Limited has been cited for 5 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 Sauflon Pharmaceuticals Limited come from?
All FDA import refusal data for Sauflon Pharmaceuticals 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.