Daiichi Sankyo Co., Ltd.
⚠️ Moderate Risk
FEI: 3006222711 • Chuo, Tokyo • JAPAN
FEI Number
3006222711
Location
Chuo, Tokyo
Country
JAPANAddress
3 5-1 NIHOMBASHIHONCHO, , Chuo, 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
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).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/28/2025 | 61LDA43PRASUGREL HYDROCHLORIDE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/8/2020 | 64PDJ04TRANEXAMIC ACID (HEMOSTATIC) | Division of West Coast Imports (DWCI) | |
| 12/8/2020 | 64PDA04TRANEXAMIC ACID (HEMOSTATIC) | Division of West Coast Imports (DWCI) | |
| 8/15/2016 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 4/20/2016 | 62CCA68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Daiichi Sankyo Co., Ltd.'s FDA import refusal history?
Daiichi Sankyo Co., Ltd. (FEI: 3006222711) has 5 FDA import refusal record(s) in our database, spanning from 4/20/2016 to 5/28/2025.
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. Daiichi Sankyo Co., Ltd.'s FEI number is 3006222711.
What types of violations has Daiichi Sankyo Co., Ltd. received?
Daiichi Sankyo 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 Daiichi Sankyo Co., Ltd. come from?
All FDA import refusal data for Daiichi Sankyo 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.