Gambro Dasco SPA Monitors Division

⚠️ Moderate Risk

FEI: 3002807196 • Medolla, Modena • ITALY

FEI

FEI Number

3002807196

📍

Location

Medolla, Modena

🇮🇹

Country

ITALY

🏢

Address

Via Modenese 66, , Medolla, Modena, Italy

Moderate Risk

FDA Import Risk Assessment

45.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/6/2018

Latest Refusal

2/3/2006

Earliest Refusal

Score Breakdown

Violation Severity

72.0×40%

Refusal Volume

49.0×30%

Recency

0.0×20%

Frequency

15.7×10%

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

29012×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

27806×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

3412×

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
11/6/2018	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	341REGISTERED	Division of Northern Border Imports (DNBI)
11/6/2018	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	341REGISTERED	Division of Northern Border Imports (DNBI)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	2780DEVICEGMPS	New York District Office (NYK-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	2780DEVICEGMPS	New York District Office (NYK-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	2780DEVICEGMPS	New York District Office (NYK-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	2780DEVICEGMPS	Chicago District Office (CHI-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	2780DEVICEGMPS	Chicago District Office (CHI-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	2780DEVICEGMPS	Chicago District Office (CHI-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	New York District Office (NYK-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	New York District Office (NYK-DO)
2/7/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	New York District Office (NYK-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)
2/3/2006	78KDIDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	290DE IMP GMP	Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Gambro Dasco SPA Monitors Division's FDA import refusal history?

Gambro Dasco SPA Monitors Division (FEI: 3002807196) has 20 FDA import refusal record(s) in our database, spanning from 2/3/2006 to 11/6/2018.

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. Gambro Dasco SPA Monitors Division's FEI number is 3002807196.

What types of violations has Gambro Dasco SPA Monitors Division received?

Gambro Dasco SPA Monitors Division has been cited for 3 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 Gambro Dasco SPA Monitors Division come from?

All FDA import refusal data for Gambro Dasco SPA Monitors Division 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.