Nissho Corporation

⚠️ High Risk

FEI: 1000258417 • Osaka, Osaka • JAPAN

FEI

FEI Number

1000258417

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN

🏢

Address

393 Honjonishi, Kita; Honjonishi; Kita, Osaka, Osaka, Japan

High Risk

FDA Import Risk Assessment

51.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/3/2005

Latest Refusal

10/1/2001

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

71.7×30%

Recency

0.0×20%

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

34163×

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).

50863×

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.

11852×

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).

Refusal History

Date	Product	Violations	Division
11/3/2005	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/14/2005	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/10/2005	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/10/2005	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
6/9/2005	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/9/2005	80FMGSTOPCOCK, I.V. SET	341REGISTERED	Division of Southeast Imports (DSEI)
3/23/2005	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/23/2005	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/23/2005	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/23/2005	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
3/22/2005	80FMGSTOPCOCK, I.V. SET	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/22/2005	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/22/2005	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/7/2005	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2005	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Division of Southeast Imports (DSEI)
3/7/2005	80FMGSTOPCOCK, I.V. SET	341REGISTERED	Division of Southeast Imports (DSEI)
2/17/2005	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/3/2005	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/3/2005	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/3/2005	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2004	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2004	80FMGSTOPCOCK, I.V. SET	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/6/2004	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/3/2004	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Division of Southeast Imports (DSEI)
11/3/2004	80FMGSTOPCOCK, I.V. SET	118NOT LISTED	Division of Southeast Imports (DSEI)
11/3/2004	80MEBPUMP, INFUSION, ELASTOMERIC	118NOT LISTED	Division of Southeast Imports (DSEI)
11/1/2004	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/18/2004	80MEBPUMP, INFUSION, ELASTOMERIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/18/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/18/2004	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
8/24/2004	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/24/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/24/2004	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/24/2004	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/17/2004	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
6/24/2004	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Division of Southeast Imports (DSEI)
6/24/2004	80FMGSTOPCOCK, I.V. SET	118NOT LISTED	Division of Southeast Imports (DSEI)
6/24/2004	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED	Division of Southeast Imports (DSEI)
5/27/2004	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Division of Southeast Imports (DSEI)
5/27/2004	80FMGSTOPCOCK, I.V. SET	118NOT LISTED	Division of Southeast Imports (DSEI)
5/27/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Division of Southeast Imports (DSEI)
5/27/2004	80MEBPUMP, INFUSION, ELASTOMERIC	118NOT LISTED	Division of Southeast Imports (DSEI)
5/27/2004	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED	Division of Southeast Imports (DSEI)
2/19/2004	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/19/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/19/2004	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/29/2004	80MEBPUMP, INFUSION, ELASTOMERIC	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/29/2004	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/29/2004	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/23/2004	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/23/2004	80MEBPUMP, INFUSION, ELASTOMERIC	118NOT LISTED 341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/9/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/9/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/9/2003	80FPASET, ADMINISTRATION, INTRAVASCULAR	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/20/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/20/2003	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/20/2003	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/10/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
7/10/2003	80FMGSTOPCOCK, I.V. SET	118NOT LISTED	Florida District Office (FLA-DO)
7/10/2003	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED	Florida District Office (FLA-DO)
5/1/2003	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/1/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/9/2003	79KGOSURGEON'S GLOVES	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/9/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/2/2003	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/2/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/12/2003	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/12/2003	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
3/6/2003	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/19/2002	78FLAMONITOR, TEMPERATURE, DIALYSIS	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/19/2002	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
9/19/2002	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
7/17/2002	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
7/17/2002	80FPASET, ADMINISTRATION, INTRAVASCULAR	118NOT LISTED 341REGISTERED	Florida District Office (FLA-DO)
3/21/2002	80FPASET, ADMINISTRATION, INTRAVASCULAR	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/7/2002	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
1/7/2002	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/18/2001	79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
12/18/2001	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Florida District Office (FLA-DO)
11/13/2001	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Florida District Office (FLA-DO)
11/2/2001	80FPASET, ADMINISTRATION, INTRAVASCULAR	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/2/2001	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/23/2001	80FMGSTOPCOCK, I.V. SET	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
10/1/2001	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Nissho Corporation's FDA import refusal history?

Nissho Corporation (FEI: 1000258417) has 85 FDA import refusal record(s) in our database, spanning from 10/1/2001 to 11/3/2005.

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. Nissho Corporation's FEI number is 1000258417.

What types of violations has Nissho Corporation received?

Nissho Corporation 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 Nissho Corporation come from?

All FDA import refusal data for Nissho 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.