TOSOH CORPORATION

⚠️ High Risk

FEI: 3012182888 • Shunan, Yamaguchi • JAPAN

FEI

FEI Number

3012182888

📍

Location

Shunan, Yamaguchi

🇯🇵

Country

JAPAN

🏢

Address

Toso (Kabu) Nan'Yokojo, Yamaguti 4560; Kaisei-Cho, Shunan, Yamaguchi, Japan

High Risk

FDA Import Risk Assessment

59.2

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

9/1/2022

Latest Refusal

1/30/2019

Earliest Refusal

Score Breakdown

Violation Severity

59.0×40%

Refusal Volume

63.6×30%

Recency

32.5×20%

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

Violation Summary

50851×

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.

328022×

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.

11814×

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).

3418×

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).

Refusal History

Date	Product	Violations	Division
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81JPDHEMOGLOBIN A2 QUANTITATION	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81GHHFIBRIN SPLIT PRODUCTS	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	75JITCALIBRATOR, SECONDARY	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	82MOIANTIGEN, TUMOR MARKER, BREAST	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	75NBCTEST, NATRIURETIC PEPTIDE	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)	508NO 510(K)	Division of Northern Border Imports (DNBI)
9/1/2022	82JZOSYSTEM, TEST, THYROID AUTOANTIBODY	508NO 510(K)	Division of Northern Border Imports (DNBI)
3/20/2019	81JPDHEMOGLOBIN A2 QUANTITATION	508NO 510(K)	Division of Northern Border Imports (DNBI)
3/20/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	508NO 510(K)	Division of Northern Border Imports (DNBI)
3/20/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81JPDHEMOGLOBIN A2 QUANTITATION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81JPDHEMOGLOBIN A2 QUANTITATION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81JPDHEMOGLOBIN A2 QUANTITATION	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
3/5/2019	81LCPASSAY, GLYCOSYLATED HEMOGLOBIN	118NOT LISTED 3280FRNMFGREG 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	75NBCTEST, NATRIURETIC PEPTIDE	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	82LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	75JHIRADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	81KSJSYSTEM FOR THE IDENTIFICATION OF HEPATITIS B ANTIGEN	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	83LOMTEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)
1/30/2019	75NBCTEST, NATRIURETIC PEPTIDE	3280FRNMFGREG 341REGISTERED 508NO 510(K)	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is TOSOH CORPORATION's FDA import refusal history?

TOSOH CORPORATION (FEI: 3012182888) has 51 FDA import refusal record(s) in our database, spanning from 1/30/2019 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 3012182888.

What types of violations has TOSOH CORPORATION received?

TOSOH CORPORATION 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 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.