SOOFT Italia S.p.A.
⚠️ Moderate Risk
FEI: 3013114561 • Montegiorgio, Fermo • ITALY
FEI Number
3013114561
Location
Montegiorgio, Fermo
Country
ITALYAddress
Contrada Molino 17, , Montegiorgio, Fermo, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
Frequently Asked Questions
What is SOOFT Italia S.p.A.'s FDA import refusal history?
SOOFT Italia S.p.A. (FEI: 3013114561) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2016 to 12/23/2016.
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. SOOFT Italia S.p.A.'s FEI number is 3013114561.
What types of violations has SOOFT Italia S.p.A. received?
SOOFT Italia 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 SOOFT Italia S.p.A. come from?
All FDA import refusal data for SOOFT Italia 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.