Qufu Zhenmei Biotechnology Co Ltd
⚠️ Moderate Risk
FEI: 3010640736 • Shandong • CHINA
FEI Number
3010640736
Location
Shandong
Country
CHINAAddress
12 West Fuyuan 11th St, , Shandong, , 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).
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 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).
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 |
|---|---|---|---|
| 6/21/2016 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/18/2015 | 53PC99OTHER COSMETIC RAW MATERIALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/18/2015 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Qufu Zhenmei Biotechnology Co Ltd's FDA import refusal history?
Qufu Zhenmei Biotechnology Co Ltd (FEI: 3010640736) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2015 to 6/21/2016.
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. Qufu Zhenmei Biotechnology Co Ltd's FEI number is 3010640736.
What types of violations has Qufu Zhenmei Biotechnology Co Ltd received?
Qufu Zhenmei Biotechnology Co Ltd 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 Qufu Zhenmei Biotechnology Co Ltd come from?
All FDA import refusal data for Qufu Zhenmei Biotechnology 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.