Herbex Co., Ltd.

⚠️ Moderate Risk

FEI: 3003594804 • Kobe • JAPAN

FEI

FEI Number

3003594804

📍

Location

Kobe

🇯🇵

Country

JAPAN

🏢

Address

6-1-301,Igazuka,Nishihirano,Mika, , Kobe, , Japan

Moderate Risk

FDA Import Risk Assessment

44.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/30/2002

Latest Refusal

7/25/2002

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

48.2×30%

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

34118×

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).

50818×

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.

1181×

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
12/30/2002	53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)	118NOT LISTED	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	89IMAPACK, HEAT, MOIST	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHDPAD, MENSTRUAL, UNSCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHLPAD, MENSTRUAL, SCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHLPAD, MENSTRUAL, SCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHLPAD, MENSTRUAL, SCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHLPAD, MENSTRUAL, SCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHLPAD, MENSTRUAL, SCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHLPAD, MENSTRUAL, SCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
7/25/2002	85HHLPAD, MENSTRUAL, SCENTED	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Herbex Co., Ltd.'s FDA import refusal history?

Herbex Co., Ltd. (FEI: 3003594804) has 19 FDA import refusal record(s) in our database, spanning from 7/25/2002 to 12/30/2002.

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. Herbex Co., Ltd.'s FEI number is 3003594804.

What types of violations has Herbex Co., Ltd. received?

Herbex 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 Herbex Co., Ltd. come from?

All FDA import refusal data for Herbex 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.