Tosoh Corporation
⚠️ High Risk
FEI: 2967 • Minato, Tokyo • JAPAN
FEI
FEI Number
2967
📍
Location
Minato, Tokyo
🇯🇵
Country
JAPAN🏢
Address
3 Chome 8-2 Shiba-Koen First Bldg., Higashiazabu, Minato, Tokyo, Japan
High Risk
FDA Import Risk Assessment
63.3
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
93
Total Refusals
5
Unique Violations
9/1/2022
Latest Refusal
7/2/2018
Earliest Refusal
Score Breakdown
Violation Severity
62.1×40%
Refusal Volume
73.1×30%
Recency
32.8×20%
Frequency
100.0×10%
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
50839×
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
47931×
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
11826×
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).
3416×
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).
32804×
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | Division of Northern Border Imports (DNBI) | |
| 9/1/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | Division of Northern Border Imports (DNBI) | |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/23/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81JPDHEMOGLOBIN A2 QUANTITATION | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 81GHHFIBRIN SPLIT PRODUCTS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 81GHHFIBRIN SPLIT PRODUCTS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 82MOIANTIGEN, TUMOR MARKER, BREAST | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 82MOIANTIGEN, TUMOR MARKER, BREAST | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 75JITCALIBRATOR, SECONDARY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 75JITCALIBRATOR, SECONDARY | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/25/2022 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 82MOIANTIGEN, TUMOR MARKER, BREAST | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 82DDCTHYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 75NEOSYSTEM, TEST, OSTEOCALCIN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/10/2022 | 82MOIANTIGEN, TUMOR MARKER, BREAST | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JITCALIBRATOR, SECONDARY | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81GHHFIBRIN SPLIT PRODUCTS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JITCALIBRATOR, SECONDARY | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81GHHFIBRIN SPLIT PRODUCTS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81GHHFIBRIN SPLIT PRODUCTS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 82MSWSYSTEM, TEST, THYROGLOBULIN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JITCALIBRATOR, SECONDARY | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81GHHFIBRIN SPLIT PRODUCTS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81GHHFIBRIN SPLIT PRODUCTS | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN) | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 12/27/2021 | 75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 10/12/2018 | 81JPDHEMOGLOBIN A2 QUANTITATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/2/2018 | 81JPDHEMOGLOBIN A2 QUANTITATION | Division of Northern Border Imports (DNBI) | |
| 7/2/2018 | 81JPDHEMOGLOBIN A2 QUANTITATION | Division of Northern Border Imports (DNBI) | |
| 7/2/2018 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | Division of Northern Border Imports (DNBI) | |
| 7/2/2018 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | Division of Northern Border Imports (DNBI) | |
| 7/2/2018 | 81LCPASSAY, GLYCOSYLATED HEMOGLOBIN | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Tosoh Corporation's FDA import refusal history?
Tosoh Corporation (FEI: 2967) has 93 FDA import refusal record(s) in our database, spanning from 7/2/2018 to 9/1/2022.
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. Tosoh Corporation's FEI number is 2967.
What types of violations has Tosoh Corporation received?
Tosoh Corporation 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 Tosoh Corporation come from?
All FDA import refusal data for Tosoh Corporation 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.