Rohto Pharmaceutical Co., Ltd. (Ueno Plant)
✅ Low Risk
FEI: 3003722237 • Iga, MIE • JAPAN
FEI Number
3003722237
Location
Iga, MIE
Country
JAPANAddress
7 Chome 3 Ueno Technocenter, Yumegaoka, Iga, MIE, Japan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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
Frequently Asked Questions
What is Rohto Pharmaceutical Co., Ltd. (Ueno Plant)'s FDA import refusal history?
Rohto Pharmaceutical Co., Ltd. (Ueno Plant) (FEI: 3003722237) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2017 to 3/29/2017.
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. Rohto Pharmaceutical Co., Ltd. (Ueno Plant)'s FEI number is 3003722237.
What types of violations has Rohto Pharmaceutical Co., Ltd. (Ueno Plant) received?
Rohto Pharmaceutical Co., Ltd. (Ueno Plant) 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 Rohto Pharmaceutical Co., Ltd. (Ueno Plant) come from?
All FDA import refusal data for Rohto Pharmaceutical Co., Ltd. (Ueno Plant) 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.