Otsuka Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3010531572 • Chiyoda, Tokyo • JAPAN
FEI Number
3010531572
Location
Chiyoda, Tokyo
Country
JAPANAddress
2 Chome 9, Kandatsukasa-Machi, Chiyoda, Tokyo, 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
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2024 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2022 | 58HCA99ENDOCRINE-METABOLIC AGENT, NEC | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 10/9/2018 | 54ACR99VITAMIN, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 10/9/2018 | 30FYH99BEVERAGE BASE OF NON-FRUIT ORIGIN, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 4/16/2018 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 54AYY13VITAMIN C (ASCORBIC ACID) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 3/2/2017 | 30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 2/13/2017 | 30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 10/3/2007 | 54AYY99VITAMIN, N.E.C. | 218LIST INGRE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Otsuka Pharmaceutical Co., Ltd.'s FDA import refusal history?
Otsuka Pharmaceutical Co., Ltd. (FEI: 3010531572) has 12 FDA import refusal record(s) in our database, spanning from 10/3/2007 to 9/24/2024.
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. Otsuka Pharmaceutical Co., Ltd.'s FEI number is 3010531572.
What types of violations has Otsuka Pharmaceutical Co., Ltd. received?
Otsuka Pharmaceutical 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 Otsuka Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Otsuka 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.