Hubei Kangzheng Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3010580682 • Anlu, Hubei • 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
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2021 | 65FBK06WATER, PURIFIED (EYEWASH) | 3600REFUSE EI | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Hubei Kangzheng Pharmaceutical Co., Ltd.'s FDA import refusal history?
Hubei Kangzheng Pharmaceutical Co., Ltd. (FEI: 3010580682) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2021 to 10/21/2021.
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. Hubei Kangzheng Pharmaceutical Co., Ltd.'s FEI number is 3010580682.
What types of violations has Hubei Kangzheng Pharmaceutical Co., Ltd. received?
Hubei Kangzheng Pharmaceutical Co., Ltd. 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 Hubei Kangzheng Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Hubei Kangzheng 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.