Formaggia Srl
⚠️ Moderate Risk
FEI: 3005787843 • Capannone • ITALY
FEI Number
3005787843
Location
Capannone
Country
ITALYAddress
Valleambrosia de Rozzano (MI), Via Varalli 1, Capannone, , 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2013 | 84GXYELECTRODE, CUTANEOUS | Cincinnati District Office (CIN-DO) | |
| 8/28/2007 | 84GXYELECTRODE, CUTANEOUS | 84RX DEVICE | Cincinnati District Office (CIN-DO) |
| 6/29/2006 | 84GXYELECTRODE, CUTANEOUS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Formaggia Srl's FDA import refusal history?
Formaggia Srl (FEI: 3005787843) has 3 FDA import refusal record(s) in our database, spanning from 6/29/2006 to 11/7/2013.
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. Formaggia Srl's FEI number is 3005787843.
What types of violations has Formaggia Srl received?
Formaggia Srl has been cited for 5 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 Formaggia Srl come from?
All FDA import refusal data for Formaggia Srl 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.