Direzione Gruppo
⚠️ Moderate Risk
FEI: 3002635770 • Piacenza, Piacenza • ITALY
FEI Number
3002635770
Location
Piacenza, Piacenza
Country
ITALYAddress
Via Toscana 2, , Piacenza, Piacenza, 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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 3/14/2002 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/9/2001 | 61FDB05AVOPARCIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Direzione Gruppo's FDA import refusal history?
Direzione Gruppo (FEI: 3002635770) has 3 FDA import refusal record(s) in our database, spanning from 11/9/2001 to 5/21/2002.
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. Direzione Gruppo's FEI number is 3002635770.
What types of violations has Direzione Gruppo received?
Direzione Gruppo 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 Direzione Gruppo come from?
All FDA import refusal data for Direzione Gruppo 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.