A.R.M. Skin Essentials Corporation
⚠️ Moderate Risk
FEI: 3011148123 • Quezon City, National Capital Region • PHILIPPINES
FEI Number
3011148123
Location
Quezon City, National Capital Region
Country
PHILIPPINESAddress
23 F. Bautista, Matulac Bldg, Quezon City, National Capital Region, 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.
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 |
|---|---|---|---|
| 11/24/2015 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/24/2015 | 65LAY99PROTECTANT N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/24/2015 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is A.R.M. Skin Essentials Corporation's FDA import refusal history?
A.R.M. Skin Essentials Corporation (FEI: 3011148123) has 3 FDA import refusal record(s) in our database, spanning from 11/24/2015 to 11/24/2015.
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. A.R.M. Skin Essentials Corporation's FEI number is 3011148123.
What types of violations has A.R.M. Skin Essentials Corporation received?
A.R.M. Skin Essentials Corporation 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 A.R.M. Skin Essentials Corporation come from?
All FDA import refusal data for A.R.M. Skin Essentials Corporation 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.