Nikkiso Ltd - Shizuoka Plant

⚠️ Moderate Risk

FEI: 3002807721 • Makinohara, Shizuoka • JAPAN

FEI

FEI Number

3002807721

📍

Location

Makinohara, Shizuoka

🇯🇵

Country

JAPAN

🏢

Address

498 1, Shizutani; Shizuoka-Ken, Makinohara, Shizuoka, Japan

Moderate Risk

FDA Import Risk Assessment

34.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

3/9/2010

Latest Refusal

4/5/2007

Earliest Refusal

Score Breakdown

Violation Severity

51.3×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

30.7×10%

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

5087×

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.

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).

1183×

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
3/9/2010	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED	Florida District Office (FLA-DO)
12/5/2009	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
9/14/2009	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	118NOT LISTED	Florida District Office (FLA-DO)
4/21/2009	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
3/25/2009	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Division of Southeast Imports (DSEI)
4/5/2007	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/5/2007	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/5/2007	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)
4/5/2007	78FKPSYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT	341REGISTERED 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Nikkiso Ltd - Shizuoka Plant's FDA import refusal history?

Nikkiso Ltd - Shizuoka Plant (FEI: 3002807721) has 9 FDA import refusal record(s) in our database, spanning from 4/5/2007 to 3/9/2010.

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. Nikkiso Ltd - Shizuoka Plant's FEI number is 3002807721.

What types of violations has Nikkiso Ltd - Shizuoka Plant received?

Nikkiso Ltd - Shizuoka Plant 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 Nikkiso Ltd - Shizuoka Plant come from?

All FDA import refusal data for Nikkiso Ltd - Shizuoka Plant 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.