Xiamen Xinshixian Foodstuff Co., LTD
⚠️ Moderate Risk
FEI: 3007708559 • Xiamen, Fujian • CHINA
FEI Number
3007708559
Location
Xiamen, Fujian
Country
CHINAAddress
Dadeng Crossing, Xinxing Street; Xiangan, Xiamen, Fujian, 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).
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2013 | 79LYUACCESSORY, SURGICAL APPAREL | Chicago District Office (CHI-DO) | |
| 12/20/2013 | 79LYUACCESSORY, SURGICAL APPAREL | Chicago District Office (CHI-DO) | |
| 6/29/2009 | 25JGC01CARROT (ROOT & TUBER VEGETABLE) | 241PESTICIDE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Xiamen Xinshixian Foodstuff Co., LTD's FDA import refusal history?
Xiamen Xinshixian Foodstuff Co., LTD (FEI: 3007708559) has 3 FDA import refusal record(s) in our database, spanning from 6/29/2009 to 12/20/2013.
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. Xiamen Xinshixian Foodstuff Co., LTD's FEI number is 3007708559.
What types of violations has Xiamen Xinshixian Foodstuff Co., LTD received?
Xiamen Xinshixian Foodstuff Co., LTD has been cited for 5 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 Xiamen Xinshixian Foodstuff Co., LTD come from?
All FDA import refusal data for Xiamen Xinshixian Foodstuff 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.