SUNEVA MEDICAL, INC
⚠️ Moderate Risk
FEI: 3003707320 • San Diego, CA • UNITED STATES
FEI Number
3003707320
Location
San Diego, CA
Country
UNITED STATESAddress
5870 Pacific Center Blvd, , 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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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 |
|---|---|---|---|
| 4/13/2017 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 4/13/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/13/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 4/13/2017 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SUNEVA MEDICAL, INC's FDA import refusal history?
SUNEVA MEDICAL, INC (FEI: 3003707320) has 4 FDA import refusal record(s) in our database, spanning from 4/13/2017 to 4/13/2017.
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. SUNEVA MEDICAL, INC's FEI number is 3003707320.
What types of violations has SUNEVA MEDICAL, INC received?
SUNEVA MEDICAL, INC 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 SUNEVA MEDICAL, INC come from?
All FDA import refusal data for SUNEVA MEDICAL, INC 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.