Simsek Biscuits and Food Industry Co.

⚠️ Moderate Risk

FEI: 3009442999 • Karaman, Karaman • TURKEY

FEI

FEI Number

3009442999

📍

Location

Karaman, Karaman

🇹🇷

Country

TURKEY

🏢

Address

Organize Sanayi Bolgesi 14. Cad. No. 1, , Karaman, Karaman, Turkey

Moderate Risk

FDA Import Risk Assessment

45.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/9/2012

Latest Refusal

11/9/2012

Earliest Refusal

Score Breakdown

Violation Severity

53.5×40%

Refusal Volume

48.2×30%

Recency

0.0×20%

Frequency

100.0×10%

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

21817×

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.

20405×

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.

114×

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).

Refusal History

Date	Product	Violations	Division
11/9/2012	03AGT03BISCUITS	2040SULFITELBL 218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03AGT03BISCUITS	2040SULFITELBL 218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03AGT03BISCUITS	2040SULFITELBL 218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03AGT03BISCUITS	2040SULFITELBL 218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03AGT03BISCUITS	2040SULFITELBL 218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	34GBT01CHOCOLATE CANDY BAR, WITH NUTS AND FRUIT	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03NGT01CAKE,CUSTARD OR CREAM FILLED	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03NGT01CAKE,CUSTARD OR CREAM FILLED	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03NGT01CAKE,CUSTARD OR CREAM FILLED	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03NGT01CAKE,CUSTARD OR CREAM FILLED	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03NGT01CAKE,CUSTARD OR CREAM FILLED	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03JGT09FRUIT/FRUIT FLAVORED FILLED/ICED COOKIES,BISCUITS AND WAFERS	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03JGT06FRUIT FILLED FILLED/ICED COOKIES,BISCUITS AND WAFERS	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03JGT05NUT FILLED/ICED COOKIES,BISCUITS AND WAFERS	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03JGT01VANILLA FILLED/ICED COOKIES,BISCUITS AND WAFERS	218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03JGT09FRUIT/FRUIT FLAVORED FILLED/ICED COOKIES,BISCUITS AND WAFERS	11UNSAFE COL 218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	03JGT06FRUIT FILLED FILLED/ICED COOKIES,BISCUITS AND WAFERS	11UNSAFE COL 218LIST INGRE	Division of Northeast Imports (DNEI)
11/9/2012	34GGT07MIXED OR ASSORTED CHOCOLATE CANDIES (BARS, BOXES, LOOSE FORM), WITH NUTS AND FRUIT	11UNSAFE COL	Division of Northeast Imports (DNEI)
11/9/2012	34GGT07MIXED OR ASSORTED CHOCOLATE CANDIES (BARS, BOXES, LOOSE FORM), WITH NUTS AND FRUIT	11UNSAFE COL	Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Simsek Biscuits and Food Industry Co.'s FDA import refusal history?

Simsek Biscuits and Food Industry Co. (FEI: 3009442999) has 19 FDA import refusal record(s) in our database, spanning from 11/9/2012 to 11/9/2012.

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. Simsek Biscuits and Food Industry Co.'s FEI number is 3009442999.

What types of violations has Simsek Biscuits and Food Industry Co. received?

Simsek Biscuits and Food Industry Co. 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 Simsek Biscuits and Food Industry Co. come from?

All FDA import refusal data for Simsek Biscuits and Food Industry Co. 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.