Kyowa Hakko Kogyo Co Ltd
⚠️ Moderate Risk
FEI: 1000157701 • Chiyoda Ku, Tokyo • JAPAN
FEI Number
1000157701
Location
Chiyoda Ku, Tokyo
Country
JAPANAddress
6-1 Otemachi 1-Chome, , Chiyoda Ku, Tokyo, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
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).
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
Frequently Asked Questions
What is Kyowa Hakko Kogyo Co Ltd's FDA import refusal history?
Kyowa Hakko Kogyo Co Ltd (FEI: 1000157701) has 3 FDA import refusal record(s) in our database, spanning from 11/21/2005 to 1/16/2014.
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. Kyowa Hakko Kogyo Co Ltd's FEI number is 1000157701.
What types of violations has Kyowa Hakko Kogyo Co Ltd received?
Kyowa Hakko Kogyo 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 Kyowa Hakko Kogyo Co Ltd come from?
All FDA import refusal data for Kyowa Hakko Kogyo 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.