Gulsan Gida San. Tic. A.S.

⚠️ Moderate Risk

FEI: 3004289674 • Melikgazi, Kayseri • TURKEY

FEI

FEI Number

3004289674

📍

Location

Melikgazi, Kayseri

🇹🇷

Country

TURKEY

🏢

Address

Anbar Mah., Organize Cad. No 4, Melikgazi, Kayseri, Turkey

Moderate Risk

FDA Import Risk Assessment

46.3

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/30/2012

Latest Refusal

10/16/2006

Earliest Refusal

Score Breakdown

Violation Severity

81.3×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

18.2×10%

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

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).

754×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

2602×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4882×

HEALTH C

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 bears an unauthorized nutrient content/health claim.

2511×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

Refusal History

Date	Product	Violations	Division
10/30/2012	21KMT13PEACH, JUICE, PIT FRUIT JUICES OR CONCENTRATES	251POISONOUS	Los Angeles District Office (LOS-DO)
11/23/2009	22KCT04SOURSOP, JUICE, OTHER FRUIT JUICES OR CONCENTRATES	11UNSAFE COL	Cincinnati District Office (CIN-DO)
11/23/2009	22KCT04SOURSOP, JUICE, OTHER FRUIT JUICES OR CONCENTRATES	11UNSAFE COL	Cincinnati District Office (CIN-DO)
11/23/2009	22KCT04SOURSOP, JUICE, OTHER FRUIT JUICES OR CONCENTRATES	11UNSAFE COL	Cincinnati District Office (CIN-DO)
11/23/2009	22KCT04SOURSOP, JUICE, OTHER FRUIT JUICES OR CONCENTRATES	11UNSAFE COL	Cincinnati District Office (CIN-DO)
6/23/2009	30BCT99FRUIT BEVERAGE BASES, LIQUID, N.E.C.	11UNSAFE COL 260FALSE 488HEALTH C	Southwest Import District Office (SWI-DO)
6/23/2009	30BCT99FRUIT BEVERAGE BASES, LIQUID, N.E.C.	11UNSAFE COL 260FALSE 488HEALTH C	Southwest Import District Office (SWI-DO)
10/16/2006	22KCY01POMEGRANATE, JUICE, OTHER FRUIT JUICES OR CONCENTRATES	75UNAPPROVED	Seattle District Office (SEA-DO)
10/16/2006	22KCY01POMEGRANATE, JUICE, OTHER FRUIT JUICES OR CONCENTRATES	75UNAPPROVED	Seattle District Office (SEA-DO)
10/16/2006	22KCY01POMEGRANATE, JUICE, OTHER FRUIT JUICES OR CONCENTRATES	75UNAPPROVED	Seattle District Office (SEA-DO)
10/16/2006	66VAL99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Gulsan Gida San. Tic. A.S.'s FDA import refusal history?

Gulsan Gida San. Tic. A.S. (FEI: 3004289674) has 11 FDA import refusal record(s) in our database, spanning from 10/16/2006 to 10/30/2012.

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. Gulsan Gida San. Tic. A.S.'s FEI number is 3004289674.

What types of violations has Gulsan Gida San. Tic. A.S. received?

Gulsan Gida San. Tic. A.S. has been cited for 5 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 Gulsan Gida San. Tic. A.S. come from?

All FDA import refusal data for Gulsan Gida San. Tic. A.S. 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.