Nipro Corporation

⚠️ High Risk

FEI: 3000247873 • Osaka, Osaka • JAPAN

FEI

FEI Number

3000247873

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN

🏢

Address

Nipuro (Kabu), 3 Chome 9-3; Honjonishi; Kita, Osaka, Osaka, Japan

High Risk

FDA Import Risk Assessment

60.8

LowModerateHighCritical

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

Statistics

122

Total Refusals

Unique Violations

1/26/2024

Latest Refusal

4/5/2004

Earliest Refusal

Score Breakdown

Violation Severity

48.1×40%

Refusal Volume

77.4×30%

Recency

60.9×20%

Frequency

61.5×10%

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

34174×

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).

50854×

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.

11841×

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).

32802×

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.

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

751×

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

Date	Product	Violations	Division
1/26/2024	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	508NO 510(K)	Division of Southeast Imports (DSEI)
10/19/2022	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	118NOT LISTED	Division of Southeast Imports (DSEI)
8/1/2022	74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2022	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	118NOT LISTED	Division of Southeast Imports (DSEI)
6/14/2022	80FMGSTOPCOCK, I.V. SET	118NOT LISTED	Division of Southeast Imports (DSEI)
7/16/2020	66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Southeast Imports (DSEI)
7/8/2020	80MEGSYRINGE, ANTISTICK	118NOT LISTED	Division of Southeast Imports (DSEI)
11/18/2019	80FMINEEDLE, HYPODERMIC, SINGLE LUMEN	118NOT LISTED	Division of Southeast Imports (DSEI)
8/22/2018	74DXECATHETER, EMBOLECTOMY	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
11/15/2011	83JTODISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION	118NOT LISTED 16DIRECTIONS 333LACKS FIRM	New Orleans District Office (NOL-DO)
8/13/2009	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	508NO 510(K)	Division of Southeast Imports (DSEI)
4/21/2009	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
3/26/2009	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	508NO 510(K)	Division of Southeast Imports (DSEI)
2/12/2009	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/12/2009	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
1/26/2009	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
1/26/2009	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
1/26/2009	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED	Florida District Office (FLA-DO)
1/26/2009	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED	Florida District Office (FLA-DO)
12/19/2008	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	237NO PMA	Division of Southeast Imports (DSEI)
12/12/2008	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/12/2008	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
11/21/2008	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
11/21/2008	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
11/13/2008	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Division of Southeast Imports (DSEI)
10/20/2008	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
10/20/2008	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
9/22/2008	80FRNPUMP, INFUSION	118NOT LISTED	Florida District Office (FLA-DO)
9/22/2008	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED	Florida District Office (FLA-DO)
9/9/2008	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED	Division of Southeast Imports (DSEI)
8/25/2008	80FRNPUMP, INFUSION	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/25/2008	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/25/2008	73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/11/2008	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED	Florida District Office (FLA-DO)
8/11/2008	80FRNPUMP, INFUSION	118NOT LISTED	Florida District Office (FLA-DO)
8/11/2008	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED	Florida District Office (FLA-DO)
8/5/2008	74OFMPHLEBOTOMY BLOOD COLLECTION KIT	118NOT LISTED 508NO 510(K)	Seattle District Office (SEA-DO)
7/22/2008	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
7/22/2008	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
6/18/2008	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED	Division of Southeast Imports (DSEI)
4/29/2008	80FOZCATHETER, INTRAVASCULAR, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/20/2007	80FRNPUMP, INFUSION	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
12/20/2007	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED	Division of Southeast Imports (DSEI)
10/1/2007	80MIANEEDLE, SPINAL, SHORT TERM	476NO REGISTR	Florida District Office (FLA-DO)
9/21/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
8/7/2007	80MEBPUMP, INFUSION, ELASTOMERIC	341REGISTERED	Florida District Office (FLA-DO)
8/7/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Florida District Office (FLA-DO)
8/7/2007	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
8/7/2007	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Florida District Office (FLA-DO)
7/10/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Division of Southeast Imports (DSEI)
7/10/2007	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Division of Southeast Imports (DSEI)
7/10/2007	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Division of Southeast Imports (DSEI)
7/6/2007	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
5/29/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	508NO 510(K)	Florida District Office (FLA-DO)
5/29/2007	80MEBPUMP, INFUSION, ELASTOMERIC	508NO 510(K)	Florida District Office (FLA-DO)
5/29/2007	80MIANEEDLE, SPINAL, SHORT TERM	508NO 510(K)	Florida District Office (FLA-DO)
5/4/2007	80MEBPUMP, INFUSION, ELASTOMERIC	118NOT LISTED	Florida District Office (FLA-DO)
4/11/2007	80MEBPUMP, INFUSION, ELASTOMERIC	118NOT LISTED	Florida District Office (FLA-DO)
4/11/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
4/11/2007	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED	Florida District Office (FLA-DO)
3/28/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Division of Southeast Imports (DSEI)
3/28/2007	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Division of Southeast Imports (DSEI)
2/22/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2007	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/8/2007	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/8/2007	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED 508NO 510(K)	Florida District Office (FLA-DO)
2/8/2007	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Florida District Office (FLA-DO)
12/11/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Florida District Office (FLA-DO)
12/11/2006	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
12/11/2006	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Florida District Office (FLA-DO)
11/27/2006	80MEBPUMP, INFUSION, ELASTOMERIC	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
11/27/2006	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
10/24/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
10/24/2006	80MEBPUMP, INFUSION, ELASTOMERIC	118NOT LISTED	Florida District Office (FLA-DO)
10/24/2006	80MIANEEDLE, SPINAL, SHORT TERM	118NOT LISTED	Florida District Office (FLA-DO)
10/24/2006	79KGXTAPE AND BANDAGE, ADHESIVE	118NOT LISTED	Florida District Office (FLA-DO)
10/11/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Florida District Office (FLA-DO)
10/11/2006	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
10/11/2006	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Florida District Office (FLA-DO)
10/11/2006	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED	Florida District Office (FLA-DO)
10/4/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/21/2006	80FRNPUMP, INFUSION	118NOT LISTED	Florida District Office (FLA-DO)
9/20/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	118NOT LISTED	Florida District Office (FLA-DO)
9/12/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Florida District Office (FLA-DO)
9/12/2006	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
9/11/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED	Division of Southeast Imports (DSEI)
9/11/2006	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Division of Southeast Imports (DSEI)
9/11/2006	79KGXTAPE AND BANDAGE, ADHESIVE	341REGISTERED	Division of Southeast Imports (DSEI)
8/21/2006	80FRNPUMP, INFUSION	118NOT LISTED	Florida District Office (FLA-DO)
8/21/2006	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED	Florida District Office (FLA-DO)
7/18/2006	80FRNPUMP, INFUSION	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
6/22/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
6/22/2006	79KKXDRAPE, SURGICAL	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/19/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/19/2006	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
5/2/2006	80MIANEEDLE, SPINAL, SHORT TERM	341REGISTERED	Florida District Office (FLA-DO)
4/5/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
4/5/2006	80FMGSTOPCOCK, I.V. SET	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
2/17/2006	78FJIDIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Nipro Corporation's FDA import refusal history?

Nipro Corporation (FEI: 3000247873) has 122 FDA import refusal record(s) in our database, spanning from 4/5/2004 to 1/26/2024.

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. Nipro Corporation's FEI number is 3000247873.

What types of violations has Nipro Corporation received?

Nipro Corporation has been cited for 9 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 Nipro Corporation come from?

All FDA import refusal data for Nipro 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.