Santen Pharmaceutical Co Ltd
⚠️ Moderate Risk
FEI: 3010271740 • Osaka-shi, Osaka-fu • JAPAN
FEI Number
3010271740
Location
Osaka-shi, Osaka-fu
Country
JAPANAddress
4 20 Ofukacho Kita Ku, , Osaka-shi, Osaka-fu, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2019 | 62OAY26DORZOLAMIDE HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2017 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Santen Pharmaceutical Co Ltd's FDA import refusal history?
Santen Pharmaceutical Co Ltd (FEI: 3010271740) has 3 FDA import refusal record(s) in our database, spanning from 12/29/2017 to 5/22/2024.
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. Santen Pharmaceutical Co Ltd's FEI number is 3010271740.
What types of violations has Santen Pharmaceutical Co Ltd received?
Santen 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 Santen Pharmaceutical Co Ltd come from?
All FDA import refusal data for Santen 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.