Societa Italiana Medicinali Scandicci, S.I.M.S. Srl
⚠️ Moderate Risk
FEI: 3001657436 • Reggello, Florence • ITALY
FEI Number
3001657436
Location
Reggello, Florence
Country
ITALYAddress
Localita Montanino Al Filarone 125, , Reggello, Florence, 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).
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 |
|---|---|---|---|
| 1/9/2006 | 64BIR50TORSEMIDE (DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/13/2004 | 62OCS44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/29/2002 | 64BCS04AMILORIDE HCL (DIURETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Societa Italiana Medicinali Scandicci, S.I.M.S. Srl's FDA import refusal history?
Societa Italiana Medicinali Scandicci, S.I.M.S. Srl (FEI: 3001657436) has 3 FDA import refusal record(s) in our database, spanning from 7/29/2002 to 1/9/2006.
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. Societa Italiana Medicinali Scandicci, S.I.M.S. Srl's FEI number is 3001657436.
What types of violations has Societa Italiana Medicinali Scandicci, S.I.M.S. Srl received?
Societa Italiana Medicinali Scandicci, S.I.M.S. Srl 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 Societa Italiana Medicinali Scandicci, S.I.M.S. Srl come from?
All FDA import refusal data for Societa Italiana Medicinali Scandicci, S.I.M.S. Srl 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.