TK PHARMACEUTICAL CO LTD
⚠️ Moderate Risk
FEI: 3022990118 • Saitama, Saitama • JAPAN
FEI Number
3022990118
Location
Saitama, Saitama
Country
JAPANAddress
433-2, Katayanagi; Minuma, Saitama, Saitama, 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
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).
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).
Refusal History
Frequently Asked Questions
What is TK PHARMACEUTICAL CO LTD's FDA import refusal history?
TK PHARMACEUTICAL CO LTD (FEI: 3022990118) has 1 FDA import refusal record(s) in our database, spanning from 8/22/2023 to 8/22/2023.
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. TK PHARMACEUTICAL CO LTD's FEI number is 3022990118.
What types of violations has TK PHARMACEUTICAL CO LTD received?
TK PHARMACEUTICAL CO LTD has been cited for 2 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 TK PHARMACEUTICAL CO LTD come from?
All FDA import refusal data for TK 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.