Zhejiang Huahai Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003999190 • Linhai, Zhejiang • CHINA
FEI Number
3003999190
Location
Linhai, Zhejiang
Country
CHINAAddress
Xunqiao Town, , Linhai, 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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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
Frequently Asked Questions
What is Zhejiang Huahai Pharmaceutical Co., Ltd.'s FDA import refusal history?
Zhejiang Huahai Pharmaceutical Co., Ltd. (FEI: 3003999190) has 2 FDA import refusal record(s) in our database, spanning from 2/27/2023 to 4/22/2024.
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. Zhejiang Huahai Pharmaceutical Co., Ltd.'s FEI number is 3003999190.
What types of violations has Zhejiang Huahai Pharmaceutical Co., Ltd. received?
Zhejiang Huahai Pharmaceutical 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 Zhejiang Huahai Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Zhejiang Huahai Pharmaceutical 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.