Misawa Medical Industry Co. Ltd. Headquarters)
⚠️ Moderate Risk
FEI: 392 • Edogawa, Tokyo • JAPAN
FEI Number
392
Location
Edogawa, Tokyo
Country
JAPANAddress
7 Chome 17-6, Hirai, Edogawa, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2005 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/20/2005 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/20/2005 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/20/2005 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/20/2005 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 7/28/2005 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Misawa Medical Industry Co. Ltd. Headquarters)'s FDA import refusal history?
Misawa Medical Industry Co. Ltd. Headquarters) (FEI: 392) has 6 FDA import refusal record(s) in our database, spanning from 7/28/2005 to 9/20/2005.
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. Misawa Medical Industry Co. Ltd. Headquarters)'s FEI number is 392.
What types of violations has Misawa Medical Industry Co. Ltd. Headquarters) received?
Misawa Medical Industry Co. Ltd. Headquarters) 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 Misawa Medical Industry Co. Ltd. Headquarters) come from?
All FDA import refusal data for Misawa Medical Industry Co. Ltd. Headquarters) 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.