Sterne Equipment Co., Ltd.
⚠️ Moderate Risk
FEI: 7434 • Brampton, Ontario • CANADA
FEI Number
7434
Location
Brampton, Ontario
Country
CANADAAddress
20 Strathearn Ave Suite 4, , Brampton, Ontario, 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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2013 | 90IZLSYSTEM, X-RAY, MOBILE | Detroit District Office (DET-DO) | |
| 8/18/2011 | 90IZLSYSTEM, X-RAY, MOBILE | 47NON STD | New York District Office (NYK-DO) |
| 8/18/2011 | 90IZLSYSTEM, X-RAY, MOBILE | 47NON STD | New York District Office (NYK-DO) |
| 8/18/2011 | 90IZLSYSTEM, X-RAY, MOBILE | 47NON STD | New York District Office (NYK-DO) |
| 12/11/2009 | 90IZLSYSTEM, X-RAY, MOBILE | Detroit District Office (DET-DO) | |
| 12/11/2009 | 90IZLSYSTEM, X-RAY, MOBILE | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Sterne Equipment Co., Ltd.'s FDA import refusal history?
Sterne Equipment Co., Ltd. (FEI: 7434) has 6 FDA import refusal record(s) in our database, spanning from 12/11/2009 to 9/5/2013.
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. Sterne Equipment Co., Ltd.'s FEI number is 7434.
What types of violations has Sterne Equipment Co., Ltd. received?
Sterne Equipment Co., 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 Sterne Equipment Co., Ltd. come from?
All FDA import refusal data for Sterne Equipment Co., 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.