Sato Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 1000421090 • 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2017 | 60LBY99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/31/2016 | 61TAA11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/28/2011 | 76EFWTOOTHBRUSH, MANUAL | Los Angeles District Office (LOS-DO) | |
| 12/28/2011 | 89IMDPACK, HOT OR COLD, DISPOSABLE | Los Angeles District Office (LOS-DO) | |
| 10/1/2009 | 79KGXTAPE AND BANDAGE, ADHESIVE | Seattle District Office (SEA-DO) | |
| 7/29/2009 | 60LBQ99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 60LBJ99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 7/29/2009 | 60LAJ99ANALGESIC, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/26/2008 | 60GBY99ALCOHOL DETERRENT, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sato Pharmaceutical Co., Ltd's FDA import refusal history?
Sato Pharmaceutical Co., Ltd (FEI: 1000421090) has 9 FDA import refusal record(s) in our database, spanning from 10/26/2008 to 3/21/2017.
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 1000421090.
What types of violations has Sato Pharmaceutical Co., Ltd received?
Sato Pharmaceutical 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 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.