Indaco Srl
⚠️ Moderate Risk
FEI: 3005237621 • Filiano, Potenza • ITALY
FEI Number
3005237621
Location
Filiano, Potenza
Country
ITALYAddress
Contrada Iscalunga, , Filiano, Potenza, 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
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 |
|---|---|---|---|
| 1/5/2017 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89IQIORTHOSIS, LIMB BRACE | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89IQIORTHOSIS, LIMB BRACE | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89IPYORTHOSIS, LUMBO-SACRAL | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 341REGISTERED | New York District Office (NYK-DO) |
| 1/5/2017 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Indaco Srl's FDA import refusal history?
Indaco Srl (FEI: 3005237621) has 9 FDA import refusal record(s) in our database, spanning from 1/5/2017 to 1/5/2017.
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. Indaco Srl's FEI number is 3005237621.
What types of violations has Indaco Srl received?
Indaco 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 Indaco Srl come from?
All FDA import refusal data for Indaco 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.