Alterego Di Bisanti Luigi
⚠️ Moderate Risk
FEI: 3004833536 • Lecce, Lecce • ITALY
FEI Number
3004833536
Location
Lecce, Lecce
Country
ITALYAddress
Via di Vaste 9/A, , Lecce, Lecce, 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).
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 |
|---|---|---|---|
| 3/8/2005 | 79NABGAUZE/SPONGE, NONRESORBABLE FOR EXTERNAL USE | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 3/8/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 3/8/2005 | 56KCA70RIFAMPIN | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Alterego Di Bisanti Luigi's FDA import refusal history?
Alterego Di Bisanti Luigi (FEI: 3004833536) has 3 FDA import refusal record(s) in our database, spanning from 3/8/2005 to 3/8/2005.
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. Alterego Di Bisanti Luigi's FEI number is 3004833536.
What types of violations has Alterego Di Bisanti Luigi received?
Alterego Di Bisanti Luigi has been cited for 2 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 Alterego Di Bisanti Luigi come from?
All FDA import refusal data for Alterego Di Bisanti Luigi 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.