Sicor Societa' Italiana Corticosteroidi S.r.l.
⚠️ Moderate Risk
FEI: 3002808100 • Santhia, Vercelli • ITALY
FEI Number
3002808100
Location
Santhia, Vercelli
Country
ITALYAddress
Via Tenuta Sant Alessandro Snc, , Santhia, Vercelli, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 3/13/2018 | 61MCS99ANTI-CONVULSANT, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 8/11/2015 | 62ICS97VALRUBICIN (ANTI-NEOPLASTIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/11/2015 | 62ICS97VALRUBICIN (ANTI-NEOPLASTIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 8/11/2015 | 62ICS97VALRUBICIN (ANTI-NEOPLASTIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/14/2004 | 64LCS61TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/21/2004 | 64LCZ28FLUOCINONIDE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/14/2003 | 62GAM35FLUNISOLIDE ACETATE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/15/2002 | 62GAM35FLUNISOLIDE ACETATE (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) | |
| 11/15/2002 | 62GAM35FLUNISOLIDE ACETATE (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) | |
| 11/15/2002 | 62GAM35FLUNISOLIDE ACETATE (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/15/2002 | 62GAM35FLUNISOLIDE ACETATE (ANTI-INFLAMMATORY) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sicor Societa' Italiana Corticosteroidi S.r.l.'s FDA import refusal history?
Sicor Societa' Italiana Corticosteroidi S.r.l. (FEI: 3002808100) has 20 FDA import refusal record(s) in our database, spanning from 11/15/2002 to 3/13/2018.
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. Sicor Societa' Italiana Corticosteroidi S.r.l.'s FEI number is 3002808100.
What types of violations has Sicor Societa' Italiana Corticosteroidi S.r.l. received?
Sicor Societa' Italiana Corticosteroidi S.r.l. 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 Sicor Societa' Italiana Corticosteroidi S.r.l. come from?
All FDA import refusal data for Sicor Societa' Italiana Corticosteroidi S.r.l. 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.