FIS - Fabbrica Italiana Sintetici S.p.A.
⚠️ Moderate Risk
FEI: 3002806961 • Montecchio Maggiore, Vicenza • ITALY
FEI Number
3002806961
Location
Montecchio Maggiore, Vicenza
Country
ITALYAddress
Viale Milano 26, , Montecchio Maggiore, Vicenza, 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
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2017 | 61NCB69GABAPENTIN (ANTI-DEPRESSANT) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/12/2014 | 61HCS32NITROFURANTOIN (ANTI-BACTERIAL) | Division of Northeast Imports (DNEI) | |
| 5/30/2014 | 61HCS32NITROFURANTOIN (ANTI-BACTERIAL) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/27/2011 | 64MCS01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/4/2010 | 64MCS01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/7/2006 | 61HCS32NITROFURANTOIN (ANTI-BACTERIAL) | New York District Office (NYK-DO) | |
| 6/26/2006 | 61HCS32NITROFURANTOIN (ANTI-BACTERIAL) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/16/2005 | 61WCS04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/16/2005 | 61WCS04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/15/2002 | 61WCS04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is FIS - Fabbrica Italiana Sintetici S.p.A.'s FDA import refusal history?
FIS - Fabbrica Italiana Sintetici S.p.A. (FEI: 3002806961) has 10 FDA import refusal record(s) in our database, spanning from 4/15/2002 to 6/13/2017.
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. FIS - Fabbrica Italiana Sintetici S.p.A.'s FEI number is 3002806961.
What types of violations has FIS - Fabbrica Italiana Sintetici S.p.A. received?
FIS - Fabbrica Italiana Sintetici 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 FIS - Fabbrica Italiana Sintetici S.p.A. come from?
All FDA import refusal data for FIS - Fabbrica Italiana Sintetici 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.