Industria Farmaceutica Nova Argentia Spa
⚠️ High Risk
FEI: 3016436027 • Gorgonzola, Milan • ITALY
FEI Number
3016436027
Location
Gorgonzola, Milan
Country
ITALYAddress
Via Carlo Porta 49, , Gorgonzola, 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).
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.
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 |
|---|---|---|---|
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60SCA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61GCA04NALIDIXIC ACID (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62LCO40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60WCA18NICLOSAMIDE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 63ECA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61TCA17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60CDM09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 63DCA01ACETAZOLAMIDE (CARBONIC ANHYDRASE INHIBITOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCP18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61TCA17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61TCA17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/25/2015 | 62LAY37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Northeast Imports (DNEI) | |
| 9/9/2011 | 62LCM50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/24/2007 | 61GCA50SULFADOXINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 60WCA18NICLOSAMIDE (ANTHELMINTIC) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 65QCA37AMINOPHYLLINE (RELAXANT) | New Orleans District Office (NOL-DO) | |
| 3/31/2006 | 61HCA22ETHAMBUTOL HYDROCHLORIDE (ANTI-BACTERIAL) | San Francisco District Office (SAN-DO) | |
| 12/28/2005 | 61HCA24ISONIAZID (ANTI-BACTERIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Industria Farmaceutica Nova Argentia Spa's FDA import refusal history?
Industria Farmaceutica Nova Argentia Spa (FEI: 3016436027) has 29 FDA import refusal record(s) in our database, spanning from 12/28/2005 to 3/23/2017.
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. Industria Farmaceutica Nova Argentia Spa's FEI number is 3016436027.
What types of violations has Industria Farmaceutica Nova Argentia Spa received?
Industria Farmaceutica Nova Argentia Spa 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 Industria Farmaceutica Nova Argentia Spa come from?
All FDA import refusal data for Industria Farmaceutica Nova Argentia Spa 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.