Diana Stalder Professional Skin Care
⚠️ Moderate Risk
FEI: 3007016001 • Mandaluyong City • PHILIPPINES
FEI Number
3007016001
Location
Mandaluyong City
Country
PHILIPPINESAddress
Unit 302 Edsa Central Pavilion Shaw Blvd, , Mandaluyong 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/27/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 9/27/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 9/27/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/27/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 9/27/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 9/27/2011 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 8/6/2008 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/6/2008 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Diana Stalder Professional Skin Care's FDA import refusal history?
Diana Stalder Professional Skin Care (FEI: 3007016001) has 8 FDA import refusal record(s) in our database, spanning from 8/6/2008 to 9/27/2011.
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. Diana Stalder Professional Skin Care's FEI number is 3007016001.
What types of violations has Diana Stalder Professional Skin Care received?
Diana Stalder Professional Skin Care 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 Diana Stalder Professional Skin Care come from?
All FDA import refusal data for Diana Stalder Professional Skin Care 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.