Celgene Cellular Therapeutics
⚠️ Moderate Risk
FEI: 3000206490 • Warren, NJ • UNITED STATES
FEI Number
3000206490
Location
Warren, NJ
Country
UNITED STATESAddress
7 Powderhorn Dr, , Warren, NJ, 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.
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 |
|---|---|---|---|
| 12/21/2004 | 65VAC40THALIDOMIDE (SEDATIVE) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/18/2003 | 65VIY40THALIDOMIDE (SEDATIVE) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 11/19/2002 | 65VCF40THALIDOMIDE (SEDATIVE) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 3/9/2002 | 65VCE40THALIDOMIDE (SEDATIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Celgene Cellular Therapeutics's FDA import refusal history?
Celgene Cellular Therapeutics (FEI: 3000206490) has 4 FDA import refusal record(s) in our database, spanning from 3/9/2002 to 12/21/2004.
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. Celgene Cellular Therapeutics's FEI number is 3000206490.
What types of violations has Celgene Cellular Therapeutics received?
Celgene Cellular Therapeutics 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 Celgene Cellular Therapeutics come from?
All FDA import refusal data for Celgene Cellular Therapeutics 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.