Olon SpA
⚠️ High Risk
FEI: 3002808159 • Casaletto Lodigiano, Lodi • ITALY
FEI Number
3002808159
Location
Casaletto Lodigiano, Lodi
Country
ITALYAddress
Via Livelli 1, Frazione Mairano, Casaletto Lodigiano, Lodi, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2023 | 61WCS18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 12/6/2017 | 61WCT04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southwest Imports (DSWI) | |
| 7/21/2009 | 61KDS13CLIDINIUM BROMIDE (ANTI-CHOLINERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/1/2008 | 63BCS26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/21/2007 | 62OBY39LABETALOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | New Orleans District Office (NOL-DO) | |
| 12/21/2004 | 62KCS08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/23/2003 | 61NCS44NORTRIPTYLINE HCL (ANTI-DEPRESSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/22/2003 | 61NCS03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/22/2003 | 64BCS41TRICHLORMETHIAZIDE (DIURETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/31/2002 | 61NCS05BUPROPION HCL (ANTI-DEPRESSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 12/31/2002 | 65QCS60CYCLOBENZAPRINE HYDROCHLORIDE (RELAXANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/25/2002 | 61WCZ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 7/25/2002 | 61WCZ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 6/25/2002 | 61NCS03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/25/2002 | 61NCS03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Olon SpA's FDA import refusal history?
Olon SpA (FEI: 3002808159) has 15 FDA import refusal record(s) in our database, spanning from 6/25/2002 to 4/10/2023.
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 SpA's FEI number is 3002808159.
What types of violations has Olon SpA received?
Olon SpA has been cited for 6 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 SpA come from?
All FDA import refusal data for Olon SpA 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.