Patheon Italia S.p.A.
⚠️ High Risk
FEI: 3003065803 • Monza, Monza E della Brianza • ITALY
FEI Number
3003065803
Location
Monza, Monza E della Brianza
Country
ITALYAddress
Viale Gian Battista Stucchi 110, , Monza, Monza E della Brianza, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/24/2023 | 62VAS99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/8/2020 | 77KCPSYRINGE, ENT | Division of Southeast Imports (DSEI) | |
| 5/12/2017 | 56YIY99ANTIBIOTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/17/2015 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/17/2015 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/22/2014 | 66VRK99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 5/22/2013 | 56YIS99ANTIBIOTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/7/2013 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/9/2011 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Patheon Italia S.p.A.'s FDA import refusal history?
Patheon Italia S.p.A. (FEI: 3003065803) has 12 FDA import refusal record(s) in our database, spanning from 9/9/2011 to 9/3/2025.
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. Patheon Italia S.p.A.'s FEI number is 3003065803.
What types of violations has Patheon Italia S.p.A. received?
Patheon Italia S.p.A. has been cited for 6 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 Patheon Italia S.p.A. come from?
All FDA import refusal data for Patheon Italia 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.