Catalent Pharma Solutions
⚠️ Moderate Risk
FEI: 2245314 • Allendale, NJ • UNITED STATES
FEI Number
2245314
Location
Allendale, NJ
Country
UNITED STATESAddress
75 Commerce Dr, , Allendale, 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
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 |
|---|---|---|---|
| 12/28/2011 | 60LIA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/19/2007 | 60BDB01AMMONIUM CHLORIDE (ACIDIFIER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/25/2006 | 63XIS99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/30/2006 | 62VIY32LAMIVUDINE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/10/2006 | 63XIS99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Catalent Pharma Solutions's FDA import refusal history?
Catalent Pharma Solutions (FEI: 2245314) has 7 FDA import refusal record(s) in our database, spanning from 11/19/2004 to 12/28/2011.
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. Catalent Pharma Solutions's FEI number is 2245314.
What types of violations has Catalent Pharma Solutions received?
Catalent Pharma Solutions 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 Catalent Pharma Solutions come from?
All FDA import refusal data for Catalent Pharma Solutions 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.