Sigma Tau
⚠️ Moderate Risk
FEI: 1000327754 • Rome, Rome • ITALY
FEI Number
1000327754
Location
Rome, Rome
Country
ITALYAddress
Viale Shakespeare 47, , Rome, Rome, 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
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 |
|---|---|---|---|
| 2/9/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2007 | 65CCK07LEVOCARNITINE (NUTRIENT/TONIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/17/2005 | 65CCA07LEVOCARNITINE (NUTRIENT/TONIC) | New York District Office (NYK-DO) | |
| 9/15/2004 | 61GCY85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/21/2004 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sigma Tau's FDA import refusal history?
Sigma Tau (FEI: 1000327754) has 5 FDA import refusal record(s) in our database, spanning from 5/21/2004 to 2/9/2018.
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. Sigma Tau's FEI number is 1000327754.
What types of violations has Sigma Tau received?
Sigma Tau 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 Sigma Tau come from?
All FDA import refusal data for Sigma Tau 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.