QINGDAO DRIVWORLD COSMETICS CO
⚠️ Moderate Risk
FEI: 3020216877 • Qingdao • CHINA
FEI Number
3020216877
Location
Qingdao
Country
CHINAAddress
Room 1502, Bulding 6 Oak, Qingdao, , 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.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/27/2022 | 60QCO07LIDOCAINE | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 65QCK02BOTOX | Division of Southeast Imports (DSEI) | |
| 3/28/2022 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/24/2022 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 3/24/2022 | 61LAY14CHLORHEXIDINE GLUCONATE | Division of Northern Border Imports (DNBI) | |
| 3/9/2022 | 60RBY99ANOREXIC, N.E.C. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is QINGDAO DRIVWORLD COSMETICS CO's FDA import refusal history?
QINGDAO DRIVWORLD COSMETICS CO (FEI: 3020216877) has 6 FDA import refusal record(s) in our database, spanning from 3/9/2022 to 4/27/2022.
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. QINGDAO DRIVWORLD COSMETICS CO's FEI number is 3020216877.
What types of violations has QINGDAO DRIVWORLD COSMETICS CO received?
QINGDAO DRIVWORLD COSMETICS CO has been cited for 11 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 QINGDAO DRIVWORLD COSMETICS CO come from?
All FDA import refusal data for QINGDAO DRIVWORLD COSMETICS 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.