Inalco S.P.A.
⚠️ Moderate Risk
FEI: 1000225411 • Milano, MI • ITALY
FEI Number
1000225411
Location
Milano, MI
Country
ITALYAddress
Via Calabiana, 18, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2012 | 64NAY10FERRIC AMMONIUM CITRATE (HEMATINIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/25/2008 | 63HBS10LACTULOSE (CATHARTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/25/2008 | 63HBS10LACTULOSE (CATHARTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/25/2008 | 63HBS10LACTULOSE (CATHARTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/25/2005 | 63HCL10LACTULOSE (CATHARTIC) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Inalco S.P.A.'s FDA import refusal history?
Inalco S.P.A. (FEI: 1000225411) has 5 FDA import refusal record(s) in our database, spanning from 5/25/2005 to 5/24/2012.
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. Inalco S.P.A.'s FEI number is 1000225411.
What types of violations has Inalco S.P.A. received?
Inalco S.P.A. 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 Inalco S.P.A. come from?
All FDA import refusal data for Inalco 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.