Fujian Yang Zhenhua 851 Biological Technology Co. Limited
⚠️ High Risk
FEI: 3003961549 • Fuzhou, Fujian • CHINA
FEI Number
3003961549
Location
Fuzhou, Fujian
Country
CHINAAddress
No.15, Luoxing M.Road, Fuzhou Economic Zone Mawei District, Fuzhou, Fujian, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
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.
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).
BACTERIA
The article appears to contain a poisonous and deleterious substance which may render it injurious to health. Contains
UNFIT4FOOD
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. 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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/8/2026 | 18YHY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Division of West Coast Imports (DWCI) | |
| 3/12/2025 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/12/2018 | 18YHY99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/1/2016 | 02GET08SOYBEAN FLOUR, MEAL, OR POWDER | 3421MELAMINE | Los Angeles District Office (LOS-DO) |
| 5/20/2014 | 02GET08SOYBEAN FLOUR, MEAL, OR POWDER | 3421MELAMINE | Los Angeles District Office (LOS-DO) |
| 3/3/2009 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 1/11/2008 | 02GET08SOYBEAN FLOUR, MEAL, OR POWDER | 238UNSAFE ADD | Los Angeles District Office (LOS-DO) |
| 10/4/2006 | 30GCE99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/13/2006 | 30GCE99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/19/2005 | 30GCE99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/18/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Fujian Yang Zhenhua 851 Biological Technology Co. Limited's FDA import refusal history?
Fujian Yang Zhenhua 851 Biological Technology Co. Limited (FEI: 3003961549) has 11 FDA import refusal record(s) in our database, spanning from 7/18/2005 to 1/8/2026.
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 Yang Zhenhua 851 Biological Technology Co. Limited's FEI number is 3003961549.
What types of violations has Fujian Yang Zhenhua 851 Biological Technology Co. Limited received?
Fujian Yang Zhenhua 851 Biological Technology Co. Limited has been cited for 11 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 Yang Zhenhua 851 Biological Technology Co. Limited come from?
All FDA import refusal data for Fujian Yang Zhenhua 851 Biological Technology Co. Limited 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.