Shandong Luxi Animal Medicine Share Co., Ltd
⚠️ Moderate Risk
FEI: 3008577193 • Dezhou, Shandong • CHINA
FEI Number
3008577193
Location
Dezhou, Shandong
Country
CHINAAddress
West of Qihe County, 1 Zhouqiao Road; Qihexian, Dezhou, Shandong, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2013 | 60EQR01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | Seattle District Office (SEA-DO) | |
| 2/27/2013 | 60EQZ01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | San Francisco District Office (SAN-DO) | |
| 1/3/2013 | 60EQZ01TRILOSTANE (ADRENOCORTICAL SUPPRESSANT | 16DIRECTIONS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Shandong Luxi Animal Medicine Share Co., Ltd's FDA import refusal history?
Shandong Luxi Animal Medicine Share Co., Ltd (FEI: 3008577193) has 3 FDA import refusal record(s) in our database, spanning from 1/3/2013 to 3/14/2013.
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. Shandong Luxi Animal Medicine Share Co., Ltd's FEI number is 3008577193.
What types of violations has Shandong Luxi Animal Medicine Share Co., Ltd received?
Shandong Luxi Animal Medicine Share 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 Shandong Luxi Animal Medicine Share Co., Ltd come from?
All FDA import refusal data for Shandong Luxi Animal Medicine Share 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.