BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
⚠️ Moderate Risk
FEI: 3006555617 • Beijing, Beijing • CHINA
FEI Number
3006555617
Location
Beijing, Beijing
Country
CHINAAddress
B-1105 Sinotrans Plaza 43#, Xizhimen BeiDajie, Haidian District, Beijing, Beijing, 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 10/9/2012 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Florida District Office (FLA-DO) | |
| 12/8/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Southwest Import District Office (SWI-DO) | |
| 12/8/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Southwest Import District Office (SWI-DO) | |
| 12/8/2009 | 80LDQDEVICE, GENERAL MEDICAL | Southwest Import District Office (SWI-DO) | |
| 12/8/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Southwest Import District Office (SWI-DO) | |
| 7/29/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD's FDA import refusal history?
BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD (FEI: 3006555617) has 7 FDA import refusal record(s) in our database, spanning from 7/29/2009 to 3/2/2017.
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. BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD's FEI number is 3006555617.
What types of violations has BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD received?
BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD has been cited for 6 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 BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD come from?
All FDA import refusal data for BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT 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.