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O.R.C.E.

⚠️ High Risk

FEI: 3004966441 • Izmir • TURKEY

FEI

FEI Number

3004966441

📍

Location

Izmir

🇹🇷

Country

TURKEY
🏢

Address

Gida Tekstil Turizmkat 6/611, , Izmir, , Turkey

High Risk

FDA Import Risk Assessment

56.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
1
Unique Violations
6/17/2005
Latest Refusal
4/20/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

© ImportRefusal.com Original Analysis

Violation Summary

8319×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
6/17/2005
25YCY99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
6/17/2005
25YCY99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
6/17/2005
24FCY01EGG PLANT (FRUIT USED AS VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24KCY01EGG PLANT, WITH SAUCE
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24FCN01EGG PLANT (FRUIT USED AS VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
25YGY99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
25YCY99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
25ECY02CARROTS AND PEAS (SWEET) (MIXED VEGETABLES)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
25ECY02CARROTS AND PEAS (SWEET) (MIXED VEGETABLES)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24TCY01ARTICHOKE (LEAF & STEM VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24FEY02OKRA (FRUIT USED AS VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24TCY01ARTICHOKE (LEAF & STEM VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24ACY14STRINGBEANS
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24FCY02OKRA (FRUIT USED AS VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24FCY02OKRA (FRUIT USED AS VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
25ECY99MIXED VEGETABLES, N.E.C.
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24ACY14STRINGBEANS
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
25JCY08RED BEET (ROOT & TUBER VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)
4/20/2005
24TCY08CABBAGE (LEAF & STEM VEGETABLE)
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is O.R.C.E.'s FDA import refusal history?

O.R.C.E. (FEI: 3004966441) has 19 FDA import refusal record(s) in our database, spanning from 4/20/2005 to 6/17/2005.

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. O.R.C.E.'s FEI number is 3004966441.

What types of violations has O.R.C.E. received?

O.R.C.E. has been cited for 1 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 O.R.C.E. come from?

All FDA import refusal data for O.R.C.E. 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.