Zhejiang Qirun Daily Necessities Co., Ltd
⚠️ Moderate Risk
FEI: 3016822544 • Wenzhou, Zhejiang • CHINA
FEI Number
3016822544
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Building 6 Floor 4, Xianlu Zhipin; Industrial Zone, Wenzhou, Zhejiang, 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).
NONRX505G
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of section 502(ee) of the FD&C Act, under which a drug is deemed to be misbranded if it is a nonprescription drug that is subject to section 505G of the FD&C Act but does not comply with the requirements for marketing under said section 505G and is not the subject of an application approved under section 505 of the FD&C Act.
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 |
|---|---|---|---|
| 10/8/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 10/8/2021 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 12/4/2020 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Zhejiang Qirun Daily Necessities Co., Ltd's FDA import refusal history?
Zhejiang Qirun Daily Necessities Co., Ltd (FEI: 3016822544) has 3 FDA import refusal record(s) in our database, spanning from 12/4/2020 to 10/8/2021.
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. Zhejiang Qirun Daily Necessities Co., Ltd's FEI number is 3016822544.
What types of violations has Zhejiang Qirun Daily Necessities Co., Ltd received?
Zhejiang Qirun Daily Necessities Co., Ltd has been cited for 3 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 Zhejiang Qirun Daily Necessities Co., Ltd come from?
All FDA import refusal data for Zhejiang Qirun Daily Necessities 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.