Premier Portfolio Int Ltd
⚠️ Moderate Risk
FEI: 3011046963 • Southampton Hampshire • UNITED KINGDOM
FEI Number
3011046963
Location
Southampton Hampshire
Country
UNITED KINGDOMAddress
Testwood Park, Salisbury Road, , Southampton Hampshire, , 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).
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/2/2016 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 10/24/2014 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 10/24/2014 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Premier Portfolio Int Ltd's FDA import refusal history?
Premier Portfolio Int Ltd (FEI: 3011046963) has 3 FDA import refusal record(s) in our database, spanning from 10/24/2014 to 2/2/2016.
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. Premier Portfolio Int Ltd's FEI number is 3011046963.
What types of violations has Premier Portfolio Int Ltd received?
Premier Portfolio Int Ltd has been cited for 4 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 Premier Portfolio Int Ltd come from?
All FDA import refusal data for Premier Portfolio Int Ltd 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.