Quadra Medical SRL
⚠️ Moderate Risk
FEI: 3005396043 • Venice, IT-VI • ITALY
FEI Number
3005396043
Location
Venice, IT-VI
Country
ITALYAddress
VIA NARDA 38, 98 Romano D'Ezzelino, VIA CARTIGLIANA 143B, Venice, IT-VI, 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).
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/2/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/19/2015 | 66PBQ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2015 | 66PBQ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/19/2015 | 63VBQ99DEPIGMENTOR N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/20/2011 | 79LEJBOOTH, SUN TAN | 476NO REGISTR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Quadra Medical SRL's FDA import refusal history?
Quadra Medical SRL (FEI: 3005396043) has 6 FDA import refusal record(s) in our database, spanning from 12/20/2011 to 8/2/2016.
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. Quadra Medical SRL's FEI number is 3005396043.
What types of violations has Quadra Medical SRL received?
Quadra Medical SRL has been cited for 4 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 Quadra Medical SRL come from?
All FDA import refusal data for Quadra Medical 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.