Ryukakusan Co. Ltd.

⚠️ Moderate Risk

FEI: 3009872012 • Katori-Gun, Chiba • JAPAN

FEI

FEI Number

3009872012

📍

Location

Katori-Gun, Chiba

🇯🇵

Country

JAPAN

🏢

Address

1460-3-Azamitodai, Mito; Tako-Machi, Katori-Gun, Chiba, Japan

Moderate Risk

FDA Import Risk Assessment

49.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/22/2017

Latest Refusal

11/15/2016

Earliest Refusal

Score Breakdown

Violation Severity

88.8×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

755×

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.

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.

2511×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

Refusal History

Date	Product	Violations	Division
9/22/2017	33EGT06FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)	16DIRECTIONS 238UNSAFE ADD 251POISONOUS 75UNAPPROVED	Division of West Coast Imports (DWCI)
11/15/2016	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	Division of West Coast Imports (DWCI)
11/15/2016	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	Division of West Coast Imports (DWCI)
11/15/2016	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	Division of West Coast Imports (DWCI)
11/15/2016	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	Division of West Coast Imports (DWCI)

Frequently Asked Questions

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

Ryukakusan Co. Ltd. (FEI: 3009872012) has 5 FDA import refusal record(s) in our database, spanning from 11/15/2016 to 9/22/2017.

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. Ryukakusan Co. Ltd.'s FEI number is 3009872012.

What types of violations has Ryukakusan Co. Ltd. received?

Ryukakusan Co. Ltd. has been cited for 4 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 Ryukakusan Co. Ltd. come from?

All FDA import refusal data for Ryukakusan 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.