Samaco Trading Limited
⚠️ Moderate Risk
FEI: 3008587588 • Richmond Hill, ON • CANADA
FEI Number
3008587588
Location
Richmond Hill, ON
Country
CANADAAddress
50 Staples Ave Unit 1, , Richmond Hill, ON, Canada
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/23/2012 | 86HOISPECTACLE, MAGNIFYING | Chicago District Office (CHI-DO) | |
| 1/11/2012 | 86HOISPECTACLE, MAGNIFYING | Chicago District Office (CHI-DO) | |
| 1/11/2012 | 86HOISPECTACLE, MAGNIFYING | Chicago District Office (CHI-DO) | |
| 1/4/2012 | 86HOISPECTACLE, MAGNIFYING | Chicago District Office (CHI-DO) | |
| 1/4/2012 | 86HOISPECTACLE, MAGNIFYING | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Samaco Trading Limited's FDA import refusal history?
Samaco Trading Limited (FEI: 3008587588) has 5 FDA import refusal record(s) in our database, spanning from 1/4/2012 to 1/23/2012.
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. Samaco Trading Limited's FEI number is 3008587588.
What types of violations has Samaco Trading Limited received?
Samaco Trading Limited 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 Samaco Trading Limited come from?
All FDA import refusal data for Samaco Trading 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.