HANZHOU YONINER PHARMACEUTICAL CO. LTD.
⚠️ Moderate Risk
FEI: 3005594425 • HANGZHOU, Znejiaug • CHINA
FEI Number
3005594425
Location
HANGZHOU, Znejiaug
Country
CHINAAddress
ECONOMIC & TECHNOLOGICAL DEV. ZONE, XIAOSHAU DISTRICT, HANGZHOU, Znejiaug, 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).
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).
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/17/2007 | 20SEF03PEAR, CORE FRUIT JUICES OR CONCENTRATES | 2920PESTICIDES | Florida District Office (FLA-DO) |
| 4/11/2006 | 80KGXTAPE AND BANDAGE, ADHESIVE | New York District Office (NYK-DO) | |
| 4/11/2006 | 80KGXTAPE AND BANDAGE, ADHESIVE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is HANZHOU YONINER PHARMACEUTICAL CO. LTD.'s FDA import refusal history?
HANZHOU YONINER PHARMACEUTICAL CO. LTD. (FEI: 3005594425) has 3 FDA import refusal record(s) in our database, spanning from 4/11/2006 to 8/17/2007.
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. HANZHOU YONINER PHARMACEUTICAL CO. LTD.'s FEI number is 3005594425.
What types of violations has HANZHOU YONINER PHARMACEUTICAL CO. LTD. received?
HANZHOU YONINER PHARMACEUTICAL 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 HANZHOU YONINER PHARMACEUTICAL CO. LTD. come from?
All FDA import refusal data for HANZHOU YONINER PHARMACEUTICAL 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.