SOLCO HEALTHCARE ZHEJIANG HUAHAI
⚠️ Moderate Risk
FEI: 3016673050 • Zhejiang • CHINA
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/23/2025 | 61NIY69GABAPENTIN (ANTI-DEPRESSANT) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SOLCO HEALTHCARE ZHEJIANG HUAHAI's FDA import refusal history?
SOLCO HEALTHCARE ZHEJIANG HUAHAI (FEI: 3016673050) has 1 FDA import refusal record(s) in our database, spanning from 10/23/2025 to 10/23/2025.
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. SOLCO HEALTHCARE ZHEJIANG HUAHAI's FEI number is 3016673050.
What types of violations has SOLCO HEALTHCARE ZHEJIANG HUAHAI received?
SOLCO HEALTHCARE ZHEJIANG HUAHAI has been cited for 1 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 SOLCO HEALTHCARE ZHEJIANG HUAHAI come from?
All FDA import refusal data for SOLCO HEALTHCARE ZHEJIANG HUAHAI 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.