S.A.Franzeluta LTD

⚠️ Moderate Risk

FEI: 3009484297 • Chisinau, Chisinau • MOLDOVA

FEI

FEI Number

3009484297

📍

Location

Chisinau, Chisinau

🇲🇩

Country

MOLDOVA

🏢

Address

Sarmizegetusa 30 Street, , Chisinau, Chisinau, Moldova

Moderate Risk

FDA Import Risk Assessment

49.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/23/2013

Latest Refusal

1/13/2003

Earliest Refusal

Score Breakdown

Violation Severity

77.9×40%

Refusal Volume

52.4×30%

Recency

0.0×20%

Frequency

22.8×10%

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

Violation Summary

23815×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

28607×

VETDRUGRES

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains

32207×

NITROFURAN

The article is subject to refusal of admission in that it appears to bear or contain a food additive, namely nitrofurans, that is unsafe.

115×

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).

3244×

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)).

4822×

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.

2181×

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.

4731×

LABELING

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

Refusal History

Date	Product	Violations	Division
12/23/2013	36CCT04HONEY	238UNSAFE ADD	New York District Office (NYK-DO)
12/23/2013	36CCT04HONEY	238UNSAFE ADD	New York District Office (NYK-DO)
12/23/2013	36CCT04HONEY	238UNSAFE ADD	New York District Office (NYK-DO)
12/23/2013	36CCT04HONEY	238UNSAFE ADD	New York District Office (NYK-DO)
12/23/2013	36CCT04HONEY	238UNSAFE ADD	New York District Office (NYK-DO)
12/23/2013	36CCT04HONEY	238UNSAFE ADD	New York District Office (NYK-DO)
12/23/2013	36CCT04HONEY	238UNSAFE ADD	New York District Office (NYK-DO)
7/22/2013	36CCT04HONEY	238UNSAFE ADD 2860VETDRUGRES 3220NITROFURAN	Los Angeles District Office (LOS-DO)
7/22/2013	36CCT04HONEY	238UNSAFE ADD	Los Angeles District Office (LOS-DO)
6/13/2013	36CCT04HONEY	238UNSAFE ADD 2860VETDRUGRES 3220NITROFURAN	Los Angeles District Office (LOS-DO)
6/13/2013	36CCT04HONEY	238UNSAFE ADD 2860VETDRUGRES 3220NITROFURAN	Los Angeles District Office (LOS-DO)
6/13/2013	36CCT04HONEY	238UNSAFE ADD 2860VETDRUGRES 3220NITROFURAN	Los Angeles District Office (LOS-DO)
6/13/2013	36CCT04HONEY	238UNSAFE ADD 2860VETDRUGRES 3220NITROFURAN	Los Angeles District Office (LOS-DO)
6/13/2013	36CCT04HONEY	238UNSAFE ADD 2860VETDRUGRES 3220NITROFURAN	Los Angeles District Office (LOS-DO)
6/13/2013	36CCT04HONEY	238UNSAFE ADD 2860VETDRUGRES 3220NITROFURAN	Los Angeles District Office (LOS-DO)
1/11/2013	21CFT02CITRUS, MIXED, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED	11UNSAFE COL	Division of Northeast Imports (DNEI)
1/11/2013	21CFT01FRUIT COCKTAIL, MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED	11UNSAFE COL	Division of Northeast Imports (DNEI)
1/11/2013	21CFT01FRUIT COCKTAIL, MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED	11UNSAFE COL	Division of Northeast Imports (DNEI)
1/11/2013	20JFT04LEMON, JAM, JELLY, PRESERVES, MARMALADE, BUTTER AND CANDIED	11UNSAFE COL	Division of Northeast Imports (DNEI)
3/9/2012	03HGT09FRUIT/FRUIT FLAVORED PLAIN COOKIES, BISCUITS AND WAFERS	11UNSAFE COL	New York District Office (NYK-DO)
6/11/2010	36CGT04HONEY	324NO ENGLISH	New York District Office (NYK-DO)
6/11/2010	36CGT04HONEY	324NO ENGLISH	New York District Office (NYK-DO)
6/11/2010	36CGT04HONEY	324NO ENGLISH	New York District Office (NYK-DO)
9/26/2003	03CGN01BAGEL PREPARED DRY MIX WITHOUT MILK OR EGG	324NO ENGLISH 482NUTRIT LBL	New York District Office (NYK-DO)
1/13/2003	03RYT60WAFFLES WITHOUT CUSTARD OR CREAM FILLING	218LIST INGRE 473LABELING 482NUTRIT LBL	New York District Office (NYK-DO)

Frequently Asked Questions

What is S.A.Franzeluta LTD's FDA import refusal history?

S.A.Franzeluta LTD (FEI: 3009484297) has 25 FDA import refusal record(s) in our database, spanning from 1/13/2003 to 12/23/2013.

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. S.A.Franzeluta LTD's FEI number is 3009484297.

What types of violations has S.A.Franzeluta LTD received?

S.A.Franzeluta LTD has been cited for 8 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 S.A.Franzeluta LTD come from?

All FDA import refusal data for S.A.Franzeluta LTD 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.