Diatheva Srl
⚠️ Moderate Risk
FEI: 3004424250 • Fano, Pesaro E Urbino • ITALY
FEI Number
3004424250
Location
Fano, Pesaro E Urbino
Country
ITALYAddress
Viale Piceno 137/f, , Fano, Pesaro E Urbino, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/19/2018 | 57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 88OTURESEARCH USE ONLY/PATHOLOGY | 223FALSE | Division of Southeast Imports (DSEI) |
| 9/2/2015 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | New York District Office (NYK-DO) |
| 11/4/2005 | 83GSHANTISERA, ALL TYPES, LISTERIA MONOCYTOGENES | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/4/2005 | 83GSHANTISERA, ALL TYPES, LISTERIA MONOCYTOGENES | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Diatheva Srl's FDA import refusal history?
Diatheva Srl (FEI: 3004424250) has 6 FDA import refusal record(s) in our database, spanning from 11/4/2005 to 9/19/2018.
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. Diatheva Srl's FEI number is 3004424250.
What types of violations has Diatheva Srl received?
Diatheva Srl 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 Diatheva Srl come from?
All FDA import refusal data for Diatheva 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.