Hisamitsu Pharmaceutical Co., Inc.
⚠️ Moderate Risk
FEI: 1000266995 • Tosu, Saga • JAPAN
FEI Number
1000266995
Location
Tosu, Saga
Country
JAPANAddress
408, Tashirodaikan-Machi, Tosu, Saga, 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
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/19/2023 | 62MBD08MENTHOL (ANTI-PRURITIC) | Division of Northern Border Imports (DNBI) | |
| 10/23/2023 | 62MBY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/12/2020 | 62GCY46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2014 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | New Orleans District Office (NOL-DO) | |
| 10/28/2011 | 60LAP99ANALGESIC, N.E.C. | 473LABELING | New Orleans District Office (NOL-DO) |
| 12/15/2010 | 60LIY99ANALGESIC, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/25/2008 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Hisamitsu Pharmaceutical Co., Inc.'s FDA import refusal history?
Hisamitsu Pharmaceutical Co., Inc. (FEI: 1000266995) has 7 FDA import refusal record(s) in our database, spanning from 4/25/2008 to 12/19/2023.
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. Hisamitsu Pharmaceutical Co., Inc.'s FEI number is 1000266995.
What types of violations has Hisamitsu Pharmaceutical Co., Inc. received?
Hisamitsu Pharmaceutical Co., Inc. 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 Hisamitsu Pharmaceutical Co., Inc. come from?
All FDA import refusal data for Hisamitsu Pharmaceutical Co., Inc. 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.