Organic El.Gi. Srl

⚠️ Moderate Risk

FEI: 3007503908 • Rome, Rome • ITALY

FEI

FEI Number

3007503908

📍

Location

Rome, Rome

🇮🇹

Country

ITALY

🏢

Address

Via Citta' Di Castello 33, , Rome, Rome, Italy

Moderate Risk

FDA Import Risk Assessment

39.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/15/2011

Latest Refusal

6/19/2009

Earliest Refusal

Score Breakdown

Violation Severity

66.7×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

36.1×10%

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

835×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

4823×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

621×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

Refusal History

Date	Product	Violations	Division
2/15/2011	25RCI02TRUFFLE, BROKEN OR KIBBLED	83NO PROCESS	Philadelphia District Office (PHI-DO)
2/15/2011	25RCI02TRUFFLE, BROKEN OR KIBBLED	83NO PROCESS	Philadelphia District Office (PHI-DO)
10/8/2010	25PCE99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE	New Orleans District Office (NOL-DO)
6/19/2009	25RCI02TRUFFLE, BROKEN OR KIBBLED	482NUTRIT LBL 83NO PROCESS	Philadelphia District Office (PHI-DO)
6/19/2009	27BET99NON-STANDARDIZED DRESSING, N.E.C.	482NUTRIT LBL 83NO PROCESS	Philadelphia District Office (PHI-DO)
6/19/2009	27BEE99NON-STANDARDIZED DRESSING, N.E.C.	482NUTRIT LBL 83NO PROCESS	Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Organic El.Gi. Srl's FDA import refusal history?

Organic El.Gi. Srl (FEI: 3007503908) has 6 FDA import refusal record(s) in our database, spanning from 6/19/2009 to 2/15/2011.

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. Organic El.Gi. Srl's FEI number is 3007503908.

What types of violations has Organic El.Gi. Srl received?

Organic El.Gi. Srl 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 Organic El.Gi. Srl come from?

All FDA import refusal data for Organic El.Gi. 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.