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Iq Cosmetics

⚠️ Moderate Risk

FEI: 3008056595 • Moscow, Moscow g • RUSSIA

FEI

FEI Number

3008056595

📍

Location

Moscow, Moscow g

🇷🇺

Country

RUSSIA
🏢

Address

ul. Butyrskaya 97, , Moscow, Moscow g, Russia

Moderate Risk

FDA Import Risk Assessment

47.4
LowModerateHighCritical

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

Statistics

11
Total Refusals
6
Unique Violations
1/31/2012
Latest Refusal
10/13/2010
Earliest Refusal

Score Breakdown

Violation Severity
67.3×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
84.5×10%
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

11810×

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).

7510×

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).

3303×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

4711×

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.

4721×

NO ENGLISH

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

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
1/31/2012
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
New York District Office (NYK-DO)
12/7/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
63RBJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
62MBJ01CAMPHOR (ANTI-PRURITIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/13/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
330UNSAFE COL
75UNAPPROVED
New York District Office (NYK-DO)
10/13/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
330UNSAFE COL
75UNAPPROVED
New York District Office (NYK-DO)
10/13/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
330UNSAFE COL
75UNAPPROVED
New York District Office (NYK-DO)
10/13/2010
62MBJ08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/13/2010
62MBJ01CAMPHOR (ANTI-PRURITIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/13/2010
62MBL08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
10/13/2010
66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Iq Cosmetics's FDA import refusal history?

Iq Cosmetics (FEI: 3008056595) has 11 FDA import refusal record(s) in our database, spanning from 10/13/2010 to 1/31/2012.

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. Iq Cosmetics's FEI number is 3008056595.

What types of violations has Iq Cosmetics received?

Iq Cosmetics 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 Iq Cosmetics come from?

All FDA import refusal data for Iq Cosmetics 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.