SKIN SCIENCES LABORATORY
⚠️ Moderate Risk
FEI: 3012949531 • Pasig City • PHILIPPINES
FEI Number
3012949531
Location
Pasig City
Country
PHILIPPINESAddress
101 Central Business Park, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/18/2017 | 53LD11ARGAN OIL | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53GI05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/18/2017 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of West Coast Imports (DWCI) | |
| 9/11/2015 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/9/2014 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 8/10/2012 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/7/2012 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/7/2012 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | New Orleans District Office (NOL-DO) | |
| 8/7/2012 | 62SBY99ANTI-SEBORRHEIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2012 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 7/20/2012 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/17/2008 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 5/5/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is SKIN SCIENCES LABORATORY's FDA import refusal history?
SKIN SCIENCES LABORATORY (FEI: 3012949531) has 44 FDA import refusal record(s) in our database, spanning from 5/5/2008 to 4/18/2017.
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. SKIN SCIENCES LABORATORY's FEI number is 3012949531.
What types of violations has SKIN SCIENCES LABORATORY received?
SKIN SCIENCES LABORATORY has been cited for 3 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 SKIN SCIENCES LABORATORY come from?
All FDA import refusal data for SKIN SCIENCES LABORATORY 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.