Guangzhou Zixuan Tattoo and Permanent Makeup
⚠️ Moderate Risk
FEI: 3010647521 • Guangzhou, Guangdong • CHINA
FEI Number
3010647521
Location
Guangzhou, Guangdong
Country
CHINAAddress
Room 1156 11/F Hongxing Building, No.288, Jinzhong Cross Road, Baiyun District,, Guangzhou, Guangdong, 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
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2016 | 53YY04TATTOO INK | New Orleans District Office (NOL-DO) | |
| 2/23/2016 | 53YD04TATTOO INK | New Orleans District Office (NOL-DO) | |
| 2/23/2016 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 2/23/2016 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/23/2016 | 60LAL99ANALGESIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/23/2016 | 60QAY99ANESTHETIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/23/2016 | 60QBL56BENZOCAINE (ANESTHETIC) | New Orleans District Office (NOL-DO) | |
| 2/19/2014 | 79GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Guangzhou Zixuan Tattoo and Permanent Makeup's FDA import refusal history?
Guangzhou Zixuan Tattoo and Permanent Makeup (FEI: 3010647521) has 8 FDA import refusal record(s) in our database, spanning from 2/19/2014 to 2/23/2016.
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. Guangzhou Zixuan Tattoo and Permanent Makeup's FEI number is 3010647521.
What types of violations has Guangzhou Zixuan Tattoo and Permanent Makeup received?
Guangzhou Zixuan Tattoo and Permanent Makeup has been cited for 12 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 Guangzhou Zixuan Tattoo and Permanent Makeup come from?
All FDA import refusal data for Guangzhou Zixuan Tattoo and Permanent Makeup 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.