Contact Color S.R.L.
✅ Low Risk
FEI: 1000509643 • Rome, Rome • ITALY
FEI Number
1000509643
Location
Rome, Rome
Country
ITALYAddress
Via Ludovico di Monreale 36, , Rome, Rome, Italy
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2005 | 86HJKLENS, CONTACT, POLYMETHYLMETHACRYLATE, DIAGNOSTIC | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Contact Color S.R.L.'s FDA import refusal history?
Contact Color S.R.L. (FEI: 1000509643) has 1 FDA import refusal record(s) in our database, spanning from 4/4/2005 to 4/4/2005.
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. Contact Color S.R.L.'s FEI number is 1000509643.
What types of violations has Contact Color S.R.L. received?
Contact Color S.R.L. 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 Contact Color S.R.L. come from?
All FDA import refusal data for Contact Color S.R.L. 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.