WALLACE CAMERON INTERNATIONAL LIMITED
⚠️ Moderate Risk
FEI: 3003045589 • Wishaw, Lanarkshire • UNITED KINGDOM
FEI Number
3003045589
Location
Wishaw, Lanarkshire
Country
UNITED KINGDOMAddress
26 Netherhall Road, SCOTLAND, Wishaw, Lanarkshire, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2020 | 79LRRKIT, FIRST AID | Division of Southeast Imports (DSEI) | |
| 8/20/2004 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 8/20/2004 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is WALLACE CAMERON INTERNATIONAL LIMITED's FDA import refusal history?
WALLACE CAMERON INTERNATIONAL LIMITED (FEI: 3003045589) has 3 FDA import refusal record(s) in our database, spanning from 8/20/2004 to 6/24/2020.
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. WALLACE CAMERON INTERNATIONAL LIMITED's FEI number is 3003045589.
What types of violations has WALLACE CAMERON INTERNATIONAL LIMITED received?
WALLACE CAMERON INTERNATIONAL 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 WALLACE CAMERON INTERNATIONAL LIMITED come from?
All FDA import refusal data for WALLACE CAMERON INTERNATIONAL 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.