Alps Pharmaceutical Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 1073 • Hida, Gifu • JAPAN
FEI Number
1073
Location
Hida, Gifu
Country
JAPANAddress
10-50 2, Furukawachomukai-Machi, Hida, 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
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.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2022 | 60WQS99ANTHELMINTIC, N.E.C. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 10/25/2022 | 60WQS99ANTHELMINTIC, N.E.C. | 2280DIRSEXMPT | Division of Northern Border Imports (DNBI) |
| 6/22/2010 | 62UCR05CARBETAPENTANE CITRATE (ANTI-TUSSIVE/COLD) | New York District Office (NYK-DO) | |
| 2/17/2010 | 62UBS05CARBETAPENTANE CITRATE (ANTI-TUSSIVE/COLD) | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Alps Pharmaceutical Industrial Co., Ltd.'s FDA import refusal history?
Alps Pharmaceutical Industrial Co., Ltd. (FEI: 1073) has 4 FDA import refusal record(s) in our database, spanning from 2/17/2010 to 10/25/2022.
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. Alps Pharmaceutical Industrial Co., Ltd.'s FEI number is 1073.
What types of violations has Alps Pharmaceutical Industrial Co., Ltd. received?
Alps Pharmaceutical Industrial Co., Ltd. has been cited for 3 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 Alps Pharmaceutical Industrial Co., Ltd. come from?
All FDA import refusal data for Alps Pharmaceutical Industrial 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.