Hwasun Biotechniologist Co Ltd
⚠️ Moderate Risk
FEI: 3006983608 • Shanghai • CHINA
FEI Number
3006983608
Location
Shanghai
Country
CHINAAddress
693 Miyang Rd Rm 502 Bldg 3500, , 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
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2008 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | Seattle District Office (SEA-DO) | |
| 8/6/2008 | 61NBR55SULPIRIDE (ANTI-DEPRESSANT) | Seattle District Office (SEA-DO) | |
| 8/6/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Hwasun Biotechniologist Co Ltd's FDA import refusal history?
Hwasun Biotechniologist Co Ltd (FEI: 3006983608) has 3 FDA import refusal record(s) in our database, spanning from 8/6/2008 to 8/15/2008.
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. Hwasun Biotechniologist Co Ltd's FEI number is 3006983608.
What types of violations has Hwasun Biotechniologist Co Ltd received?
Hwasun Biotechniologist Co Ltd has been cited for 3 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 Hwasun Biotechniologist Co Ltd come from?
All FDA import refusal data for Hwasun Biotechniologist 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.