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Guangzhou Youxi Cosmetics Co. Ltd.

⚠️ Moderate Risk

FEI: 3007959500 • Guangzhou • CHINA

FEI

FEI Number

3007959500

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

No. 585 Jichang Road, , Guangzhou, , China

Moderate Risk

FDA Import Risk Assessment

46.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

21
Total Refusals
6
Unique Violations
12/3/2010
Latest Refusal
9/13/2010
Earliest Refusal

Score Breakdown

Violation Severity
53.4×40%
Refusal Volume
49.7×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47219×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

11815×

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).

7515×

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).

4712×

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.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4751×

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.

Refusal History

DateProductViolationsDivision
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
9/13/2010
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
474COSMETLBLG
475COSMETLBLG
New England District Office (NWE-DO)
9/13/2010
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New England District Office (NWE-DO)

Frequently Asked Questions

What is Guangzhou Youxi Cosmetics Co. Ltd.'s FDA import refusal history?

Guangzhou Youxi Cosmetics Co. Ltd. (FEI: 3007959500) has 21 FDA import refusal record(s) in our database, spanning from 9/13/2010 to 12/3/2010.

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 Youxi Cosmetics Co. Ltd.'s FEI number is 3007959500.

What types of violations has Guangzhou Youxi Cosmetics Co. Ltd. received?

Guangzhou Youxi Cosmetics Co. Ltd. has been cited for 6 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 Youxi Cosmetics Co. Ltd. come from?

All FDA import refusal data for Guangzhou Youxi Cosmetics 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.