Fazzini S.R.L.

⚠️ Moderate Risk

FEI: 3003197028 • Vimodrone, Milan • ITALY

FEI

FEI Number

3003197028

📍

Location

Vimodrone, Milan

🇮🇹

Country

ITALY

🏢

Address

Strada Statale 11 Padana Superiore 317, , Vimodrone, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

33.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/26/2002

Latest Refusal

6/26/2002

Earliest Refusal

Score Breakdown

Violation Severity

46.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

1186×

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).

3416×

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).

5083×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
6/26/2002	80KMHSTERILIZER, DRY HEAT	118NOT LISTED 341REGISTERED 508NO 510(K)	Southwest Import District Office (SWI-DO)
6/26/2002	74LDESTETHOSCOPE, MANUAL	118NOT LISTED 341REGISTERED 508NO 510(K)	Southwest Import District Office (SWI-DO)
6/26/2002	74DSKCOMPUTER, BLOOD-PRESSURE	118NOT LISTED 341REGISTERED 508NO 510(K)	Southwest Import District Office (SWI-DO)
6/26/2002	80KYTLIGHT, EXAMINATION, MEDICAL, BATTERY POWERED	118NOT LISTED 341REGISTERED	Southwest Import District Office (SWI-DO)
6/26/2002	80KYTLIGHT, EXAMINATION, MEDICAL, BATTERY POWERED	118NOT LISTED 341REGISTERED	Southwest Import District Office (SWI-DO)
6/26/2002	80FNJBED, MANUAL	118NOT LISTED 341REGISTERED	Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Fazzini S.R.L.'s FDA import refusal history?

Fazzini S.R.L. (FEI: 3003197028) has 6 FDA import refusal record(s) in our database, spanning from 6/26/2002 to 6/26/2002.

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. Fazzini S.R.L.'s FEI number is 3003197028.

What types of violations has Fazzini S.R.L. received?

Fazzini S.R.L. 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 Fazzini S.R.L. come from?

All FDA import refusal data for Fazzini 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.