Kawasumi Laboratories, Inc.
⚠️ Moderate Risk
FEI: 1000163068 • Minato, Tokyo • JAPAN
FEI Number
1000163068
Location
Minato, Tokyo
Country
JAPANAddress
Shinagawa Intercity Tower B, 2 Chome 15-2; Konan, Minato, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2002 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 237NO PMA | Florida District Office (FLA-DO) |
| 2/13/2002 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | 237NO PMA | Florida District Office (FLA-DO) |
| 1/4/2002 | 78LIFDIALYZER REPROCESSING SYSTEM | 237NO PMA | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Kawasumi Laboratories, Inc.'s FDA import refusal history?
Kawasumi Laboratories, Inc. (FEI: 1000163068) has 3 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 2/28/2002.
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. Kawasumi Laboratories, Inc.'s FEI number is 1000163068.
What types of violations has Kawasumi Laboratories, Inc. received?
Kawasumi Laboratories, Inc. has been cited for 1 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 Kawasumi Laboratories, Inc. come from?
All FDA import refusal data for Kawasumi Laboratories, Inc. 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.