MITSUBISHI TANABE PHARMA CORPORATION .
⚠️ Moderate Risk
FEI: 3002114823 • Osaka, Osaka • JAPAN
FEI Number
3002114823
Location
Osaka, Osaka
Country
JAPANAddress
3 Chome 2-10, Dosho-Machi; Chuo3CHOME, Osaka, Osaka, 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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/13/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2017 | 63BCB30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2008 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is MITSUBISHI TANABE PHARMA CORPORATION .'s FDA import refusal history?
MITSUBISHI TANABE PHARMA CORPORATION . (FEI: 3002114823) has 3 FDA import refusal record(s) in our database, spanning from 3/19/2008 to 3/13/2023.
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. MITSUBISHI TANABE PHARMA CORPORATION .'s FEI number is 3002114823.
What types of violations has MITSUBISHI TANABE PHARMA CORPORATION . received?
MITSUBISHI TANABE PHARMA CORPORATION . 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 MITSUBISHI TANABE PHARMA CORPORATION . come from?
All FDA import refusal data for MITSUBISHI TANABE PHARMA CORPORATION . 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.