Shanghai Soyoung Biotech
⚠️ Moderate Risk
FEI: 3008979631 • Shanghai • CHINA
FEI Number
3008979631
Location
Shanghai
Country
CHINAAddress
40-601 Lane 688 Fujian Road, , Shanghai, , 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).
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.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2015 | 61LCY99ANTI-COAGULANT, N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 1/16/2015 | 61LCY99ANTI-COAGULANT, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 1/16/2015 | 61LCY99ANTI-COAGULANT, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 6/17/2014 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/29/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 11/29/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 11/29/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 9/4/2013 | 54AYY99VITAMIN, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Soyoung Biotech's FDA import refusal history?
Shanghai Soyoung Biotech (FEI: 3008979631) has 8 FDA import refusal record(s) in our database, spanning from 9/4/2013 to 1/22/2015.
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 Soyoung Biotech's FEI number is 3008979631.
What types of violations has Shanghai Soyoung Biotech received?
Shanghai Soyoung Biotech 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 Shanghai Soyoung Biotech come from?
All FDA import refusal data for Shanghai Soyoung Biotech 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.