CRETA MEL SA
⚠️ Moderate Risk
FEI: 3004281785 • Rethymno, Rethymnis • GREECE
FEI Number
3004281785
Location
Rethymno, Rethymnis
Country
GREECEAddress
Sisses Village, , Rethymno, Rethymnis, Greece
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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.
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.
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.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
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)].
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2014 | 33GGT99SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE) | Chicago District Office (CHI-DO) | |
| 12/17/2014 | 33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 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) | Division of Northern Border Imports (DNBI) | |
| 11/16/2010 | 33JGT99SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Northern Border Imports (DNBI) | |
| 5/10/2010 | 33CGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE) | New York District Office (NYK-DO) | |
| 5/10/2010 | 36CCE04HONEY | New York District Office (NYK-DO) | |
| 5/10/2010 | 36CCE04HONEY | New York District Office (NYK-DO) | |
| 5/10/2010 | 03JGT05NUT FILLED/ICED COOKIES,BISCUITS AND WAFERS | New York District Office (NYK-DO) | |
| 5/10/2010 | 36CEE04HONEY | New York District Office (NYK-DO) | |
| 5/10/2010 | 36CCE04HONEY | New York District Office (NYK-DO) | |
| 5/10/2010 | 33CGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE) | New York District Office (NYK-DO) | |
| 5/10/2010 | 33CGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE) | 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.