ZHONGJING WANXI PHARMACEUTICAL CO
⚠️ Moderate Risk
FEI: 3016273839 • Nanyang • CHINA
FEI Number
3016273839
Location
Nanyang
Country
CHINAAddress
No. 168 Zhongjing Rd, Xixia Country, Henan, Nanyang, , 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).
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.
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.
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 |
|---|---|---|---|
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/16/2020 | 54AYR99VITAMIN, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ZHONGJING WANXI PHARMACEUTICAL CO's FDA import refusal history?
ZHONGJING WANXI PHARMACEUTICAL CO (FEI: 3016273839) has 11 FDA import refusal record(s) in our database, spanning from 3/16/2020 to 3/16/2020.
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. ZHONGJING WANXI PHARMACEUTICAL CO's FEI number is 3016273839.
What types of violations has ZHONGJING WANXI PHARMACEUTICAL CO received?
ZHONGJING WANXI PHARMACEUTICAL CO 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 ZHONGJING WANXI PHARMACEUTICAL CO come from?
All FDA import refusal data for ZHONGJING WANXI 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.