Ganeden Biotech
⚠️ Moderate Risk
FEI: 3005117803 • Beachwood, OH • UNITED STATES
FEI Number
3005117803
Location
Beachwood, OH
Country
UNITED STATESAddress
23240 Chagrin Blvd, , Beachwood, OH, United States
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2005 | 55RP32LACTOSE (PHARMACEUTIC NECESSITY - TABLET & CAPSULE DILUENT) | 342PERSONALRX | New Orleans District Office (NOL-DO) |
| 7/18/2005 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/18/2005 | 62CAY41MINOXIDIL (ANTI-HYPERTENSIVE) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/18/2005 | 64LAY37HYDROCORTISONE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ganeden Biotech's FDA import refusal history?
Ganeden Biotech (FEI: 3005117803) has 4 FDA import refusal record(s) in our database, spanning from 7/18/2005 to 7/18/2005.
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. Ganeden Biotech's FEI number is 3005117803.
What types of violations has Ganeden Biotech received?
Ganeden Biotech 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 Ganeden Biotech come from?
All FDA import refusal data for Ganeden Biotech 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.