SINOTRANS
⚠️ Moderate Risk
FEI: 3012839051 • Shenzhen, Guangdong • CHINA
FEI Number
3012839051
Location
Shenzhen, Guangdong
Country
CHINAAddress
Warehouse Bu C Floor 1, Shajing Main Street; Baoan, Shenzhen, Guangdong, 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.
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).
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2020 | 73QLSPULSE OXIMETER FOR LOW-ACUITY SETTINGS | Division of Southeast Imports (DSEI) | |
| 7/13/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 11/30/2017 | 79GFEBRUSH, DERMABRASION | Division of Southeast Imports (DSEI) | |
| 11/30/2017 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Division of Southeast Imports (DSEI) | |
| 11/30/2017 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Division of Southeast Imports (DSEI) | |
| 11/30/2017 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Division of Southeast Imports (DSEI) | |
| 6/30/2017 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SINOTRANS's FDA import refusal history?
SINOTRANS (FEI: 3012839051) has 7 FDA import refusal record(s) in our database, spanning from 6/30/2017 to 8/14/2020.
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. SINOTRANS's FEI number is 3012839051.
What types of violations has SINOTRANS received?
SINOTRANS has been cited for 7 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 SINOTRANS come from?
All FDA import refusal data for SINOTRANS 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.