Santen Pharm. Co., Ltd.
⚠️ Moderate Risk
FEI: 3002808072 • Higashi Yodogawa-Ku • JAPAN
FEI Number
3002808072
Location
Higashi Yodogawa-Ku
Country
JAPANAddress
9-19 Shimoshinjo 3-Chome, , Higashi Yodogawa-Ku, , 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
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 9/21/2015 | 65FBY06WATER, PURIFIED (EYEWASH) | Cincinnati District Office (CIN-DO) | |
| 10/6/2009 | 61HCK43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/19/2005 | 62GDK99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/22/2003 | 66RBK99VASOCONSTRICTOR N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Santen Pharm. Co., Ltd.'s FDA import refusal history?
Santen Pharm. Co., Ltd. (FEI: 3002808072) has 4 FDA import refusal record(s) in our database, spanning from 12/22/2003 to 9/21/2015.
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 Pharm. Co., Ltd.'s FEI number is 3002808072.
What types of violations has Santen Pharm. Co., Ltd. received?
Santen Pharm. Co., Ltd. has been cited for 4 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 Pharm. Co., Ltd. come from?
All FDA import refusal data for Santen Pharm. 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.