Sellers Union Co Ltd
⚠️ Moderate Risk
FEI: 3009596201 • Ningboningbo • CHINA
FEI Number
3009596201
Location
Ningboningbo
Country
CHINAAddress
19f No.1 Bldg Bningboresearch Deve, , Ningboningbo, , 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
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.
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).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2014 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | San Francisco District Office (SAN-DO) | |
| 6/27/2014 | 80FQMBANDAGE, ELASTIC | San Francisco District Office (SAN-DO) | |
| 6/27/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Sellers Union Co Ltd's FDA import refusal history?
Sellers Union Co Ltd (FEI: 3009596201) has 3 FDA import refusal record(s) in our database, spanning from 6/27/2014 to 6/27/2014.
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. Sellers Union Co Ltd's FEI number is 3009596201.
What types of violations has Sellers Union Co Ltd received?
Sellers Union 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 Sellers Union Co Ltd come from?
All FDA import refusal data for Sellers Union 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.