JHO Dome Skin Care Products
⚠️ Moderate Risk
FEI: 3005246813 • Metro Manila, National Capital Region • PHILIPPINES
FEI Number
3005246813
Location
Metro Manila, National Capital Region
Country
PHILIPPINESAddress
720A Heroes Del 96 Samson Rd, , Metro Manila, 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).
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 |
|---|---|---|---|
| 4/3/2006 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/22/2005 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/14/2005 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/29/2005 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is JHO Dome Skin Care Products's FDA import refusal history?
JHO Dome Skin Care Products (FEI: 3005246813) has 4 FDA import refusal record(s) in our database, spanning from 10/29/2005 to 4/3/2006.
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. JHO Dome Skin Care Products's FEI number is 3005246813.
What types of violations has JHO Dome Skin Care Products received?
JHO Dome Skin Care Products has been cited for 2 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 JHO Dome Skin Care Products come from?
All FDA import refusal data for JHO Dome Skin Care Products 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.