Zo Skin Health
⚠️ Moderate Risk
FEI: 3007841327 • San Diego, CA • UNITED STATES
FEI Number
3007841327
Location
San Diego, CA
Country
UNITED STATESAddress
7626 Miramar Rd Ste 3600, , San Diego, CA, United States
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 |
|---|---|---|---|
| 6/29/2012 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 65LBL11TITANIUM DIOXIDE (PROTECTANT) | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 6/29/2012 | 64XAY06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Zo Skin Health's FDA import refusal history?
Zo Skin Health (FEI: 3007841327) has 9 FDA import refusal record(s) in our database, spanning from 6/29/2012 to 6/29/2012.
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. Zo Skin Health's FEI number is 3007841327.
What types of violations has Zo Skin Health received?
Zo Skin Health 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 Zo Skin Health come from?
All FDA import refusal data for Zo Skin Health 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.