Otsuka Pharmaceutical Factory
⚠️ High Risk
FEI: 3002354276 • Naruto, Tokushima • JAPAN
FEI Number
3002354276
Location
Naruto, Tokushima
Country
JAPANAddress
115, Muyachokizu, Naruto, Tokushima, Japan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 12/1/2025 | 61LAJ14CHLORHEXIDINE GLUCONATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2023 | 55QP28HYDROPHILIC OINTMENT (PHARMACEUTIC NECESSITY - OIL IN WATER EMULSION) | Division of Northeast Imports (DNEI) | |
| 11/21/2016 | 62FAY99ANTI-INFECTIVE, TOPICAL N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/16/2012 | 61LBJ14CHLORHEXIDINE GLUCONATE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Otsuka Pharmaceutical Factory's FDA import refusal history?
Otsuka Pharmaceutical Factory (FEI: 3002354276) has 4 FDA import refusal record(s) in our database, spanning from 2/16/2012 to 12/1/2025.
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. Otsuka Pharmaceutical Factory's FEI number is 3002354276.
What types of violations has Otsuka Pharmaceutical Factory received?
Otsuka Pharmaceutical Factory 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 Otsuka Pharmaceutical Factory come from?
All FDA import refusal data for Otsuka Pharmaceutical Factory 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.