XI'AN QIYUAN KEGONGMAO CO., LTD
⚠️ Moderate Risk
FEI: 3004265006 • Xian, Shanxi • CHINA
FEI Number
3004265006
Location
Xian, Shanxi
Country
CHINAAddress
1, Panjiazhuang Industrial District, Xian, Shanxi, 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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:
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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 |
|---|---|---|---|
| 4/27/2010 | 54FBR24SENNA (HERBAL & BOTANICALS, NOT TEAS) | 2920PESTICIDES | Los Angeles District Office (LOS-DO) |
| 11/20/2008 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 11/20/2008 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/31/2007 | 66VAR99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/23/2007 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is XI'AN QIYUAN KEGONGMAO CO., LTD's FDA import refusal history?
XI'AN QIYUAN KEGONGMAO CO., LTD (FEI: 3004265006) has 5 FDA import refusal record(s) in our database, spanning from 10/23/2007 to 4/27/2010.
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. XI'AN QIYUAN KEGONGMAO CO., LTD's FEI number is 3004265006.
What types of violations has XI'AN QIYUAN KEGONGMAO CO., LTD received?
XI'AN QIYUAN KEGONGMAO CO., LTD has been cited for 8 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 XI'AN QIYUAN KEGONGMAO CO., LTD come from?
All FDA import refusal data for XI'AN QIYUAN KEGONGMAO 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.