AGSA GOMMA

⚠️ High Risk

FEI: 3014346953 • San Lazzaro Di Savena • ITALY

FEI

FEI Number

3014346953

📍

Location

San Lazzaro Di Savena

🇮🇹

Country

ITALY

🏢

Address

Po Box 7, , San Lazzaro Di Savena, , Italy

High Risk

FDA Import Risk Assessment

54.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

6/15/2023

Latest Refusal

6/15/2023

Earliest Refusal

Score Breakdown

Violation Severity

53.3×40%

Refusal Volume

44.6×30%

Recency

48.5×20%

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

22315×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

34115×

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).

50815×

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
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)
6/15/2023	80KGOSURGEON'S GLOVES	223FALSE 341REGISTERED 508NO 510(K)	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is AGSA GOMMA's FDA import refusal history?

AGSA GOMMA (FEI: 3014346953) has 15 FDA import refusal record(s) in our database, spanning from 6/15/2023 to 6/15/2023.

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. AGSA GOMMA's FEI number is 3014346953.

What types of violations has AGSA GOMMA received?

AGSA GOMMA 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 AGSA GOMMA come from?

All FDA import refusal data for AGSA GOMMA 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.