CA-MI SRL
⚠️ Moderate Risk
FEI: 3013171650 • Langhirano, Parma • ITALY
FEI Number
3013171650
Location
Langhirano, Parma
Country
ITALYAddress
Ro, Via Ugo la Malfa13 FRA, Langhirano, Parma, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2017 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2017 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2017 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2017 | 76DYNMOUTHPIECE, SALIVA EJECTOR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2017 | 76DYNMOUTHPIECE, SALIVA EJECTOR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2017 | 76DYNMOUTHPIECE, SALIVA EJECTOR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/7/2017 | 76DYNMOUTHPIECE, SALIVA EJECTOR | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CA-MI SRL's FDA import refusal history?
CA-MI SRL (FEI: 3013171650) has 7 FDA import refusal record(s) in our database, spanning from 3/7/2017 to 3/7/2017.
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. CA-MI SRL's FEI number is 3013171650.
What types of violations has CA-MI SRL received?
CA-MI SRL has been cited for 1 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 CA-MI SRL come from?
All FDA import refusal data for CA-MI 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.