Hebei Yuanzheng Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 3008613490 • Shijiazhuang, Hebei • CHINA
FEI Number
3008613490
Location
Shijiazhuang, Hebei
Country
CHINAAddress
12 Luiyuan Rd., Gaoying Town, , Shijiazhuang, Hebei, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
Frequently Asked Questions
What is Hebei Yuanzheng Pharmaceutical Co., Ltd's FDA import refusal history?
Hebei Yuanzheng Pharmaceutical Co., Ltd (FEI: 3008613490) has 1 FDA import refusal record(s) in our database, spanning from 4/15/2013 to 4/15/2013.
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. Hebei Yuanzheng Pharmaceutical Co., Ltd's FEI number is 3008613490.
What types of violations has Hebei Yuanzheng Pharmaceutical Co., Ltd received?
Hebei Yuanzheng 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 Hebei Yuanzheng Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Hebei Yuanzheng 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.