Astra Japan Corporation
⚠️ Moderate Risk
FEI: 3004046579 • Osaka • 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).
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/26/2003 | 55PA55SILICA GEL (PHARMACEUTIC NECESSITY) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/10/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 7/3/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/24/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/24/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/23/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/20/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/20/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/20/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/20/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/20/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) | |
| 6/20/2003 | 80LDQDEVICE, GENERAL MEDICAL | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Astra Japan Corporation's FDA import refusal history?
Astra Japan Corporation (FEI: 3004046579) has 12 FDA import refusal record(s) in our database, spanning from 6/20/2003 to 8/26/2003.
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. Astra Japan Corporation's FEI number is 3004046579.
What types of violations has Astra Japan Corporation received?
Astra Japan Corporation 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 Astra Japan Corporation come from?
All FDA import refusal data for Astra Japan Corporation 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.