Shenzhen Alvantis Pharma Co., Ltd.
⚠️ High Risk
FEI: 3031629929 • Shenzhen, Guangdong • CHINA
FEI Number
3031629929
Location
Shenzhen, Guangdong
Country
CHINAAddress
Room 1902, Building D3, Nanshan Wisdom Park Phase II, Xueyuan Avenue, , Shenzhen, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2025 | 56FCT99PEPTIDE N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/30/2025 | 56FCT99PEPTIDE N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/30/2025 | 56FCT99PEPTIDE N.E.C. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shenzhen Alvantis Pharma Co., Ltd.'s FDA import refusal history?
Shenzhen Alvantis Pharma Co., Ltd. (FEI: 3031629929) has 3 FDA import refusal record(s) in our database, spanning from 12/30/2025 to 12/30/2025.
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. Shenzhen Alvantis Pharma Co., Ltd.'s FEI number is 3031629929.
What types of violations has Shenzhen Alvantis Pharma Co., Ltd. received?
Shenzhen Alvantis Pharma Co., Ltd. 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 Shenzhen Alvantis Pharma Co., Ltd. come from?
All FDA import refusal data for Shenzhen Alvantis Pharma Co., Ltd. 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.