BEIJING SONG TAO HENG YE INTER.
⚠️ Moderate Risk
FEI: 3013165584 • Beijing Beijing • CHINA
FEI Number
3013165584
Location
Beijing Beijing
Country
CHINAAddress
D Co. Ltd. Rm, 702 North, 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).
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
Frequently Asked Questions
What is BEIJING SONG TAO HENG YE INTER.'s FDA import refusal history?
BEIJING SONG TAO HENG YE INTER. (FEI: 3013165584) has 1 FDA import refusal record(s) in our database, spanning from 8/23/2018 to 8/23/2018.
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 SONG TAO HENG YE INTER.'s FEI number is 3013165584.
What types of violations has BEIJING SONG TAO HENG YE INTER. received?
BEIJING SONG TAO HENG YE INTER. 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 BEIJING SONG TAO HENG YE INTER. come from?
All FDA import refusal data for BEIJING SONG TAO HENG YE INTER. 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.