GANSU WEIYUAN YANYU PHARMACEUTICAL CO.
⚠️ Moderate Risk
FEI: 3013269070 • Huiyuan County, Gansu • CHINA
FEI Number
3013269070
Location
Huiyuan County, Gansu
Country
CHINAAddress
Building B Unit 1, Huichuan; Town Industrial Zone, Huiyuan County, Gansu, 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
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:
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.
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
PESTICIDE2
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:
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
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 |
|---|---|---|---|
| 1/8/2021 | 21HGT16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE | 249FILTHY | Division of West Coast Imports (DWCI) |
| 8/23/2016 | 54FAR25SCHIZANDRA (HERBAL & BOTANICALS, NOT TEAS) | 241PESTICIDE | Los Angeles District Office (LOS-DO) |
| 12/2/2015 | 66YDJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/13/2013 | 54FAR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | Los Angeles District Office (LOS-DO) |
| 10/19/2011 | 54FAR25SCHIZANDRA (HERBAL & BOTANICALS, NOT TEAS) | 2920PESTICIDES | Los Angeles District Office (LOS-DO) |
| 10/19/2011 | 54FAR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2920PESTICIDES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is GANSU WEIYUAN YANYU PHARMACEUTICAL CO.'s FDA import refusal history?
GANSU WEIYUAN YANYU PHARMACEUTICAL CO. (FEI: 3013269070) has 6 FDA import refusal record(s) in our database, spanning from 10/19/2011 to 1/8/2021.
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. GANSU WEIYUAN YANYU PHARMACEUTICAL CO.'s FEI number is 3013269070.
What types of violations has GANSU WEIYUAN YANYU PHARMACEUTICAL CO. received?
GANSU WEIYUAN YANYU PHARMACEUTICAL CO. has been cited for 10 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 GANSU WEIYUAN YANYU PHARMACEUTICAL CO. come from?
All FDA import refusal data for GANSU WEIYUAN YANYU PHARMACEUTICAL CO. 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.