Shanghai Link Instruments Co Ltd
⚠️ Moderate Risk
FEI: 3009503888 • Shanghaishanghai • CHINA
FEI Number
3009503888
Location
Shanghaishanghai
Country
CHINAAddress
No.258 Jiamei Rd Shanghai, , Shanghaishanghai, , China
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).
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 |
|---|---|---|---|
| 3/31/2014 | 86HRJTABLE, INSTRUMENT, POWERED, OPHTHALMIC | Cincinnati District Office (CIN-DO) | |
| 3/31/2014 | 86HRJTABLE, INSTRUMENT, POWERED, OPHTHALMIC | Cincinnati District Office (CIN-DO) | |
| 5/3/2013 | 86HKNREFRACTOR, MANUAL, NON-POWERED, INCLUDING PHOROPTER | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shanghai Link Instruments Co Ltd's FDA import refusal history?
Shanghai Link Instruments Co Ltd (FEI: 3009503888) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2013 to 3/31/2014.
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. Shanghai Link Instruments Co Ltd's FEI number is 3009503888.
What types of violations has Shanghai Link Instruments Co Ltd received?
Shanghai Link Instruments Co Ltd has been cited for 3 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 Shanghai Link Instruments Co Ltd come from?
All FDA import refusal data for Shanghai Link Instruments 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.