Patheon Italia S.p.A
⚠️ Moderate Risk
FEI: 3004110157 • Ferentino, Frosinone • ITALY
FEI Number
3004110157
Location
Ferentino, Frosinone
Country
ITALYAddress
Via Morolense 5, , Ferentino, Frosinone, Italy
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2023 | 64KBK99GAS, DILUENT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/21/2023 | 57NL04GENE THERAPIES (VECTORS, GENETICALLY MODIFIED CELLS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/26/2020 | 64RCK16VASOPRESSIN (INJ) (HORMONE) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/7/2014 | 64ECZ99ENZYME N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/27/2012 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/26/2011 | 63XIY83MANNITOL (DIAGNOSTIC AID) (DRUGS) | 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: 3004110157) has 6 FDA import refusal record(s) in our database, spanning from 9/26/2011 to 2/21/2023.
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 3004110157.
What types of violations has Patheon Italia S.p.A received?
Patheon Italia S.p.A has been cited for 4 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.