Catalent Italy S.p.A.
⚠️ High Risk
FEI: 3004273375 • Aprilia, Latina • ITALY
FEI Number
3004273375
Location
Aprilia, Latina
Country
ITALYAddress
Via Nettunense km 20, 100, , Aprilia, Latina, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2025 | 62GAA82DIMETHYL SULFOXIDE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2024 | 62BDA14OMEGA-3-ACID ETHYL ESTERS (ANTI-HYPERLIPIDEMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2022 | 66YIA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 61LCY22ANTI-COAGULANT HEPARIN SOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/28/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 2/11/2011 | 53CB04EYE LOTION (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Catalent Italy S.p.A.'s FDA import refusal history?
Catalent Italy S.p.A. (FEI: 3004273375) has 6 FDA import refusal record(s) in our database, spanning from 2/11/2011 to 7/2/2025.
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 Italy S.p.A.'s FEI number is 3004273375.
What types of violations has Catalent Italy S.p.A. received?
Catalent Italy S.p.A. has been cited for 3 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 Italy S.p.A. come from?
All FDA import refusal data for Catalent Italy S.p.A. 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.