Actavis Italy Spa A Socio Unico
⚠️ High Risk
FEI: 3001116953 • Nerviano, Milan • ITALY
FEI Number
3001116953
Location
Nerviano, Milan
Country
ITALYAddress
Via Louis Pasteur 10, , Nerviano, Milan, 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/19/2023 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/15/2022 | 65FCS05WATER, FOR INJECTION, BACTERIOSTATIC, U.S.P. (PHARMACEUTIC AID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/5/2022 | 65FCS05WATER, FOR INJECTION, BACTERIOSTATIC, U.S.P. (PHARMACEUTIC AID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 56KCZ12CHLORAMPHENICOL SODIUM SUCCINATE | Division of Southeast Imports (DSEI) | |
| 10/12/2012 | 56KCY10CHLORAMPHENICOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Actavis Italy Spa A Socio Unico's FDA import refusal history?
Actavis Italy Spa A Socio Unico (FEI: 3001116953) has 6 FDA import refusal record(s) in our database, spanning from 10/12/2012 to 1/19/2024.
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. Actavis Italy Spa A Socio Unico's FEI number is 3001116953.
What types of violations has Actavis Italy Spa A Socio Unico received?
Actavis Italy Spa A Socio Unico 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 Actavis Italy Spa A Socio Unico come from?
All FDA import refusal data for Actavis Italy Spa A Socio Unico 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.