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Intelligent Skin Care, Inc.

⚠️ Moderate Risk

FEI: 3007251132 • Pasig City • PHILIPPINES

FEI

FEI Number

3007251132

📍

Location

Pasig City

🇵🇭
🏢

Address

Unit 2504-4 West Towerpse Center, , Pasig City, , Philippines

Moderate Risk

FDA Import Risk Assessment

43.9
LowModerateHighCritical

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

Statistics

9
Total Refusals
4
Unique Violations
8/28/2014
Latest Refusal
12/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
76.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
24.1×10%
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

759×

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).

1184×

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).

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
8/28/2014
62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
3/16/2011
66VBO99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
223FALSE
75UNAPPROVED
Florida District Office (FLA-DO)
3/16/2011
66VBO99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
3/16/2011
66VBO99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
3/16/2011
66VBO99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)
12/3/2010
64XAY06SALICYLIC ACID (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
64XAY06SALICYLIC ACID (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
64XAY06SALICYLIC ACID (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
12/3/2010
64XAY06SALICYLIC ACID (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Intelligent Skin Care, Inc.'s FDA import refusal history?

Intelligent Skin Care, Inc. (FEI: 3007251132) has 9 FDA import refusal record(s) in our database, spanning from 12/3/2010 to 8/28/2014.

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. Intelligent Skin Care, Inc.'s FEI number is 3007251132.

What types of violations has Intelligent Skin Care, Inc. received?

Intelligent Skin Care, Inc. has been cited for 4 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 Intelligent Skin Care, Inc. come from?

All FDA import refusal data for Intelligent Skin Care, Inc. 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.