Artsana S.p.A.
⚠️ Moderate Risk
FEI: 3002807528 • Casnate Con Bernate, Como • ITALY
FEI Number
3002807528
Location
Casnate Con Bernate, Como
Country
ITALYAddress
Via Filomena Saldarini Catelli 6/10, , Casnate Con Bernate, Como, 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).
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2015 | 62FAY17HYDROGEN PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | Division of Northeast Imports (DNEI) | |
| 8/5/2011 | 85HISCONDOM | New Orleans District Office (NOL-DO) | |
| 6/22/2007 | 80KZHINTRODUCER, SYRINGE NEEDLE | 341REGISTERED | Chicago District Office (CHI-DO) |
| 6/22/2007 | 80FMFSYRINGE, PISTON | 341REGISTERED | Chicago District Office (CHI-DO) |
| 6/22/2007 | 80FMFSYRINGE, PISTON | 341REGISTERED | Chicago District Office (CHI-DO) |
| 6/22/2007 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Chicago District Office (CHI-DO) | |
| 9/9/2004 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 9/9/2004 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/22/2004 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/22/2004 | 85HGYPUMP, BREAST, NON-POWERED | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/4/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Artsana S.p.A.'s FDA import refusal history?
Artsana S.p.A. (FEI: 3002807528) has 11 FDA import refusal record(s) in our database, spanning from 2/4/2003 to 11/25/2015.
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. Artsana S.p.A.'s FEI number is 3002807528.
What types of violations has Artsana S.p.A. received?
Artsana 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 Artsana S.p.A. come from?
All FDA import refusal data for Artsana 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.