Catalent Pharma Solutions Limited
⚠️ Moderate Risk
FEI: 3003812585 • Swindon, SWD • UNITED KINGDOM
FEI Number
3003812585
Location
Swindon, SWD
Country
UNITED KINGDOMAddress
Frankland Road, Swd, Swindon, SWD, United Kingdom
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).
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 |
|---|---|---|---|
| 1/31/2012 | 66NCY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/8/2008 | 66VAM99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/8/2008 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 2/17/2005 | 66NCY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | Atlanta District Office (ATL-DO) | |
| 2/17/2005 | 66NCY02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Catalent Pharma Solutions Limited's FDA import refusal history?
Catalent Pharma Solutions Limited (FEI: 3003812585) has 5 FDA import refusal record(s) in our database, spanning from 2/17/2005 to 1/31/2012.
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 Limited's FEI number is 3003812585.
What types of violations has Catalent Pharma Solutions Limited received?
Catalent Pharma Solutions Limited 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 Catalent Pharma Solutions Limited come from?
All FDA import refusal data for Catalent Pharma Solutions Limited 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.