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CRETA MEL SA

⚠️ Moderate Risk

FEI: 3004281785 • Rethymno, Rethymnis • GREECE

FEI

FEI Number

3004281785

📍

Location

Rethymno, Rethymnis

🇬🇷

Country

GREECE
🏢

Address

Sisses Village, , Rethymno, Rethymnis, Greece

Moderate Risk

FDA Import Risk Assessment

36.5
LowModerateHighCritical

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

Statistics

15
Total Refusals
11
Unique Violations
12/17/2014
Latest Refusal
5/10/2010
Earliest Refusal

Score Breakdown

Violation Severity
49.5×40%
Refusal Volume
44.6×30%
Recency
0.0×20%
Frequency
32.5×10%
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

48212×

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.

4738×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

116×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2744×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

3202×

LACKS FIRM

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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

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.

3282×

USUAL NAME

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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

33002×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

33202×

TRANSFAT

The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].

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.

20401×

SULFITELBL

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
12/17/2014
33GGT99SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
328USUAL NAME
3300ALLERGEN
3320TRANSFAT
482NUTRIT LBL
Chicago District Office (CHI-DO)
12/17/2014
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
328USUAL NAME
3300ALLERGEN
3320TRANSFAT
Chicago District Office (CHI-DO)
10/4/2012
33KGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE)
482NUTRIT LBL
New York District Office (NYK-DO)
10/4/2012
33AGT05CANDY BARS OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)(WITHOUT
482NUTRIT LBL
New York District Office (NYK-DO)
10/4/2012
33GGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
482NUTRIT LBL
New York District Office (NYK-DO)
11/16/2010
33JGT99SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Northern Border Imports (DNBI)
11/16/2010
33JGT99SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Northern Border Imports (DNBI)
5/10/2010
33CGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE)
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/10/2010
36CCE04HONEY
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/10/2010
36CCE04HONEY
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/10/2010
03JGT05NUT FILLED/ICED COOKIES,BISCUITS AND WAFERS
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/10/2010
36CEE04HONEY
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/10/2010
36CCE04HONEY
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/10/2010
33CGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
2040SULFITELBL
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)
5/10/2010
33CGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
473LABELING
482NUTRIT LBL
New York District Office (NYK-DO)

Frequently Asked Questions

What is CRETA MEL SA's FDA import refusal history?

CRETA MEL SA (FEI: 3004281785) has 15 FDA import refusal record(s) in our database, spanning from 5/10/2010 to 12/17/2014.

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. CRETA MEL SA's FEI number is 3004281785.

What types of violations has CRETA MEL SA received?

CRETA MEL SA has been cited for 11 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 CRETA MEL SA come from?

All FDA import refusal data for CRETA MEL SA 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.