Sato Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004055563 • Hachioji, Tokyo • JAPAN
FEI Number
3004055563
Location
Hachioji, Tokyo
Country
JAPANAddress
1468, Hazama-Machi, Hachioji, 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).
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2011 | 78FCEKIT, ENEMA, (FOR CLEANING PURPOSE) | 344WARNINGS | San Francisco District Office (SAN-DO) |
| 11/22/2011 | 61XBL08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | San Francisco District Office (SAN-DO) | |
| 11/22/2011 | 60LBE01ACETAMINOPHEN (ANALGESIC) | San Francisco District Office (SAN-DO) | |
| 11/21/2011 | 66CBA99STOOL SOFTENER N.E.C. | San Francisco District Office (SAN-DO) | |
| 11/21/2011 | 62MBJ99ANTI-PRURITIC N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Sato Pharmaceutical Co., Ltd.'s FDA import refusal history?
Sato Pharmaceutical Co., Ltd. (FEI: 3004055563) has 5 FDA import refusal record(s) in our database, spanning from 11/21/2011 to 11/22/2011.
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. Sato Pharmaceutical Co., Ltd.'s FEI number is 3004055563.
What types of violations has Sato Pharmaceutical Co., Ltd. received?
Sato Pharmaceutical Co., Ltd. has been cited for 3 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 Sato Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Sato 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.