Johnson & Johnson Medical Pty. Ltd.
⚠️ Moderate Risk
FEI: 3002315950 • Macquarie Park, New South Wales • AUSTRALIA
FEI Number
3002315950
Location
Macquarie Park, New South Wales
Country
AUSTRALIAAddress
1-5 Khartoum Rd, , Macquarie Park, New South Wales, Australia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2011 | 79FZPCLIP, IMPLANTABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 79GDWSTAPLE, IMPLANTABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 79GDOAPPLIER, SURGICAL, CLIP | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/19/2011 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Johnson & Johnson Medical Pty. Ltd.'s FDA import refusal history?
Johnson & Johnson Medical Pty. Ltd. (FEI: 3002315950) has 4 FDA import refusal record(s) in our database, spanning from 8/19/2011 to 8/19/2011.
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. Johnson & Johnson Medical Pty. Ltd.'s FEI number is 3002315950.
What types of violations has Johnson & Johnson Medical Pty. Ltd. received?
Johnson & Johnson Medical Pty. Ltd. 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 Johnson & Johnson Medical Pty. Ltd. come from?
All FDA import refusal data for Johnson & Johnson Medical Pty. 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.