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DEMETRA srl

⚠️ Moderate Risk

FEI: 3002260492 • Talamona, SO • ITALY

FEI

FEI Number

3002260492

📍

Location

Talamona, SO

🇮🇹

Country

ITALY
🏢

Address

Via Roma 751, , Talamona, SO, Italy

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

8
Total Refusals
6
Unique Violations
6/15/2018
Latest Refusal
11/26/2001
Earliest Refusal

Score Breakdown

Violation Severity
53.1×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
4.8×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

4825×

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.

623×

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).

833×

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.

2182×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3212×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

3241×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

DateProductViolationsDivision
6/15/2018
25SCT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C.
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
Division of Southeast Imports (DSEI)
6/15/2018
25SCT01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C.
218LIST INGRE
321LACKS N/C
Division of Southeast Imports (DSEI)
7/10/2014
25YEI99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
482NUTRIT LBL
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
7/10/2014
25EVI99MIXED VEGETABLES, N.E.C.
482NUTRIT LBL
Florida District Office (FLA-DO)
7/10/2014
25EVI99MIXED VEGETABLES, N.E.C.
482NUTRIT LBL
Florida District Office (FLA-DO)
7/10/2014
37JCY24GARLIC SAUCE
324NO ENGLISH
482NUTRIT LBL
Florida District Office (FLA-DO)
11/27/2001
25YYY99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
11/26/2001
25QYY01MUSHROOM, COMMON (AGARICUS BISPORUS), PIECES AND STEMS, SLICED
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is DEMETRA srl's FDA import refusal history?

DEMETRA srl (FEI: 3002260492) has 8 FDA import refusal record(s) in our database, spanning from 11/26/2001 to 6/15/2018.

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. DEMETRA srl's FEI number is 3002260492.

What types of violations has DEMETRA srl received?

DEMETRA srl has been cited for 6 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 DEMETRA srl come from?

All FDA import refusal data for DEMETRA 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.