Adaptgen Pharmaceutical Co.,Ltd.
⚠️ Moderate Risk
FEI: 3004270805 • Ena, Gifu • JAPAN
FEI Number
3004270805
Location
Ena, Gifu
Country
JAPANAddress
1788, Yamaokachokubohara, Ena, Gifu, Japan
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
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 |
|---|---|---|---|
| 9/24/2005 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Adaptgen Pharmaceutical Co.,Ltd.'s FDA import refusal history?
Adaptgen Pharmaceutical Co.,Ltd. (FEI: 3004270805) has 1 FDA import refusal record(s) in our database, spanning from 9/24/2005 to 9/24/2005.
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. Adaptgen Pharmaceutical Co.,Ltd.'s FEI number is 3004270805.
What types of violations has Adaptgen Pharmaceutical Co.,Ltd. received?
Adaptgen 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 Adaptgen Pharmaceutical Co.,Ltd. come from?
All FDA import refusal data for Adaptgen 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.