Yangzhou Huangxuan Daily Chemical Co., Ltd
⚠️ Moderate Risk
FEI: 3017262351 • Yangzhou, Jiangsu • CHINA
FEI Number
3017262351
Location
Yangzhou, Jiangsu
Country
CHINAAddress
No. 999 Phoenix Island Road, Taianzhen, Yangzhou, Jiangsu, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/8/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 2/25/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/25/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/25/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 1/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Yangzhou Huangxuan Daily Chemical Co., Ltd's FDA import refusal history?
Yangzhou Huangxuan Daily Chemical Co., Ltd (FEI: 3017262351) has 6 FDA import refusal record(s) in our database, spanning from 1/15/2021 to 3/17/2021.
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. Yangzhou Huangxuan Daily Chemical Co., Ltd's FEI number is 3017262351.
What types of violations has Yangzhou Huangxuan Daily Chemical Co., Ltd received?
Yangzhou Huangxuan Daily Chemical 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 Yangzhou Huangxuan Daily Chemical Co., Ltd come from?
All FDA import refusal data for Yangzhou Huangxuan Daily Chemical 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.