FUJIAN XIANZHILOU NUTRA-INDUSTRY CO., LTD.
⚠️ Moderate Risk
FEI: 3006992514 • Fuzhou, Fujian • CHINA
FEI Number
3006992514
Location
Fuzhou, Fujian
Country
CHINAAddress
Bldg. 9, Fuzhou Hi; Tech Zone, Fuzhou, 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NCONTACTS
The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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 |
|---|---|---|---|
| 1/30/2014 | 54GCH99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/27/2012 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is FUJIAN XIANZHILOU NUTRA-INDUSTRY CO., LTD.'s FDA import refusal history?
FUJIAN XIANZHILOU NUTRA-INDUSTRY CO., LTD. (FEI: 3006992514) has 2 FDA import refusal record(s) in our database, spanning from 12/27/2012 to 1/30/2014.
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. FUJIAN XIANZHILOU NUTRA-INDUSTRY CO., LTD.'s FEI number is 3006992514.
What types of violations has FUJIAN XIANZHILOU NUTRA-INDUSTRY CO., LTD. received?
FUJIAN XIANZHILOU NUTRA-INDUSTRY CO., LTD. has been cited for 4 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 FUJIAN XIANZHILOU NUTRA-INDUSTRY CO., LTD. come from?
All FDA import refusal data for FUJIAN XIANZHILOU NUTRA-INDUSTRY 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.