Olon S.p.A.
⚠️ Moderate Risk
FEI: 3002716636 • Rodano, Milan • ITALY
FEI Number
3002716636
Location
Rodano, Milan
Country
ITALYAddress
Strada Provinciale Rivoltana 6/7, , Rodano, Milan, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 9/24/2014 | 62ICS24HYDROXYUREA (ANTI-NEOPLASTIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 5/14/2009 | 56CIS67CEFTAZIDIME SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/14/2009 | 56CIS67CEFTAZIDIME SODIUM (CEPHALOSPORINS) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 10/11/2001 | 56DCS51PAROMOMYCIN SULFATE (AMINOGLYCOSIDES) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Olon S.p.A.'s FDA import refusal history?
Olon S.p.A. (FEI: 3002716636) has 4 FDA import refusal record(s) in our database, spanning from 10/11/2001 to 9/24/2014.
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. Olon S.p.A.'s FEI number is 3002716636.
What types of violations has Olon S.p.A. received?
Olon S.p.A. 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 Olon S.p.A. come from?
All FDA import refusal data for Olon 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.