HUIZHOU MINGFENGYUAN
⚠️ Moderate Risk
FEI: 3016742456 • Huizhou • CHINA
FEI Number
3016742456
Location
Huizhou
Country
CHINAAddress
8th Floor, No. 1 Nantan, Huizhou, , 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).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 12/2/2021 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | Division of Southeast Imports (DSEI) | |
| 7/22/2021 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 6/23/2021 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | Division of Southeast Imports (DSEI) | |
| 3/29/2021 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2021 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Division of Southeast Imports (DSEI) | |
| 3/15/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/15/2021 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 7/21/2020 | 60QDP07LIDOCAINE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HUIZHOU MINGFENGYUAN's FDA import refusal history?
HUIZHOU MINGFENGYUAN (FEI: 3016742456) has 8 FDA import refusal record(s) in our database, spanning from 7/21/2020 to 12/2/2021.
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. HUIZHOU MINGFENGYUAN's FEI number is 3016742456.
What types of violations has HUIZHOU MINGFENGYUAN received?
HUIZHOU MINGFENGYUAN has been cited for 5 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 HUIZHOU MINGFENGYUAN come from?
All FDA import refusal data for HUIZHOU MINGFENGYUAN 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.