SAMIC SNC DI MICHIELIN RENZO & C

⚠️ Moderate Risk

FEI: 3012415297 • Treviso, Treviso • ITALY

FEI

FEI Number

3012415297

📍

Location

Treviso, Treviso

🇮🇹

Country

ITALY

🏢

Address

Via Monte Santo 6/A, , Treviso, Treviso, Italy

Moderate Risk

FDA Import Risk Assessment

42.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

6/14/2017

Latest Refusal

6/14/2017

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

42.5×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

11813×

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).

328013×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

Date	Product	Violations	Division
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
6/14/2017	89KNOACCESSORIES, WHEELCHAIR	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SAMIC SNC DI MICHIELIN RENZO & C's FDA import refusal history?

SAMIC SNC DI MICHIELIN RENZO & C (FEI: 3012415297) has 13 FDA import refusal record(s) in our database, spanning from 6/14/2017 to 6/14/2017.

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. SAMIC SNC DI MICHIELIN RENZO & C's FEI number is 3012415297.

What types of violations has SAMIC SNC DI MICHIELIN RENZO & C received?

SAMIC SNC DI MICHIELIN RENZO & C 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 SAMIC SNC DI MICHIELIN RENZO & C come from?

All FDA import refusal data for SAMIC SNC DI MICHIELIN RENZO & C 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.