Daiichi Sankyo Healthcare Co, LTD
⚠️ High Risk
FEI: 3015210379 • Nihomba, Tokyo • JAPAN
FEI Number
3015210379
Location
Nihomba, Tokyo
Country
JAPANAddress
3chome 14-10, Nihombashi; Cho, Nihomba, Tokyo, 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
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).
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. 801.15(c)(1)
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/30/2025 | 64PBA04TRANEXAMIC ACID (HEMOSTATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2023 | 60LBA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 10/4/2023 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/27/2023 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/12/2023 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/14/2022 | 66NDY11LURASIDONE HYDROCHLORIDE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/21/2021 | 62UBK19PHOLCODINE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/8/2020 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/3/2019 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Division of Southeast Imports (DSEI) |
| 6/27/2019 | 53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 3260NO ENGLISH | Division of West Coast Imports (DWCI) |
| 12/29/2017 | 60LDY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2017 | 61FCA56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/30/2015 | 53LF06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Daiichi Sankyo Healthcare Co, LTD's FDA import refusal history?
Daiichi Sankyo Healthcare Co, LTD (FEI: 3015210379) has 15 FDA import refusal record(s) in our database, spanning from 9/30/2015 to 5/30/2025.
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 Healthcare Co, LTD's FEI number is 3015210379.
What types of violations has Daiichi Sankyo Healthcare Co, LTD received?
Daiichi Sankyo Healthcare Co, LTD has been cited for 5 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 Healthcare Co, LTD come from?
All FDA import refusal data for Daiichi Sankyo Healthcare 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.