Grup Italia
⚠️ Moderate Risk
FEI: 3010747933 • Milano, Mi • ITALY
FEI Number
3010747933
Location
Milano, Mi
Country
ITALYAddress
Via Carlo Vittadini 11, , Milano, Mi, 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
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 |
|---|---|---|---|
| 9/8/2015 | 60LBY69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/8/2015 | 60LBY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/29/2015 | 66SBB03BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/23/2014 | 60LCL69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Grup Italia's FDA import refusal history?
Grup Italia (FEI: 3010747933) has 4 FDA import refusal record(s) in our database, spanning from 4/23/2014 to 9/8/2015.
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. Grup Italia's FEI number is 3010747933.
What types of violations has Grup Italia received?
Grup Italia has been cited for 1 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 Grup Italia come from?
All FDA import refusal data for Grup Italia 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.