Intelligent Skin Care Inc
⚠️ Moderate Risk
FEI: 3006520708 • Pasig City • PHILIPPINES
FEI Number
3006520708
Location
Pasig City
Country
PHILIPPINESAddress
Pse Center, , Pasig City, , Philippines
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).
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.
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/15/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 12/15/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 12/15/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 9/16/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/12/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/11/2010 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/7/2010 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/24/2009 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 12/24/2009 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 1/16/2008 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Intelligent Skin Care Inc's FDA import refusal history?
Intelligent Skin Care Inc (FEI: 3006520708) has 18 FDA import refusal record(s) in our database, spanning from 1/16/2008 to 7/31/2012.
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. Intelligent Skin Care Inc's FEI number is 3006520708.
What types of violations has Intelligent Skin Care Inc received?
Intelligent Skin Care Inc 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 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.