Taiko Pharmaceutical Co., Ltd.

⚠️ High Risk

FEI: 3003448083 • Suita, Osaka • JAPAN

FEI

FEI Number

3003448083

📍

Location

Suita, Osaka

🇯🇵

Country

JAPAN

🏢

Address

3 Chome 34-14, Uchihon-Machi, Suita, Osaka, Japan

High Risk

FDA Import Risk Assessment

51.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

7/19/2012

Latest Refusal

6/16/2011

Earliest Refusal

Score Breakdown

Violation Severity

83.3×40%

Refusal Volume

35.3×30%

Recency

0.0×20%

Frequency

73.2×10%

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

757×

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).

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).

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.

Refusal History

Date	Product	Violations	Division
7/19/2012	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	San Francisco District Office (SAN-DO)
2/16/2012	66VBA99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
12/16/2011	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	New York District Office (NYK-DO)
12/16/2011	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	New York District Office (NYK-DO)
12/16/2011	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	New York District Office (NYK-DO)
6/16/2011	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	San Francisco District Office (SAN-DO)
6/16/2011	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	San Francisco District Office (SAN-DO)
6/16/2011	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	75UNAPPROVED	San Francisco District Office (SAN-DO)

Frequently Asked Questions

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

Taiko Pharmaceutical Co., Ltd. (FEI: 3003448083) has 8 FDA import refusal record(s) in our database, spanning from 6/16/2011 to 7/19/2012.

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. Taiko Pharmaceutical Co., Ltd.'s FEI number is 3003448083.

What types of violations has Taiko Pharmaceutical Co., Ltd. received?

Taiko Pharmaceutical 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 Taiko Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Taiko Pharmaceutical 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.