Phitten Co Ltd

⚠️ Moderate Risk

FEI: 3008161494 • Kyoto • JAPAN

FEI

FEI Number

3008161494

📍

Location

Kyoto

🇯🇵

Country

JAPAN

🏢

Address

678, Tearaimizu-Cho, Kyoto, , Japan

Moderate Risk

FDA Import Risk Assessment

35.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/3/2016

Latest Refusal

10/18/2007

Earliest Refusal

Score Breakdown

Violation Severity

51.5×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

Frequency

16.2×10%

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

34113×

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).

50813×

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.

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

Refusal History

Date	Product	Violations	Division
6/3/2016	29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.	238UNSAFE ADD	Los Angeles District Office (LOS-DO)
1/25/2008	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
11/7/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
11/7/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/19/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80FQMBANDAGE, ELASTIC	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80FQMBANDAGE, ELASTIC	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80FQMBANDAGE, ELASTIC	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80FQMBANDAGE, ELASTIC	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
10/18/2007	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Phitten Co Ltd's FDA import refusal history?

Phitten Co Ltd (FEI: 3008161494) has 14 FDA import refusal record(s) in our database, spanning from 10/18/2007 to 6/3/2016.

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. Phitten Co Ltd's FEI number is 3008161494.

What types of violations has Phitten Co Ltd received?

Phitten Co Ltd 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 Phitten Co Ltd come from?

All FDA import refusal data for Phitten Co Ltd 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.