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SULTANBEYLI BAHARAT AKTARIYE MAL

⚠️ Moderate Risk

FEI: 3015407053 • Istanbul • TURKEY

FEI

FEI Number

3015407053

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Dursun Mete Cevizli Mah, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/2/2019
Latest Refusal
7/2/2019
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

4821×

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.

751×

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).

Refusal History

DateProductViolationsDivision
7/2/2019
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3864NCONTACT
482NUTRIT LBL
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SULTANBEYLI BAHARAT AKTARIYE MAL's FDA import refusal history?

SULTANBEYLI BAHARAT AKTARIYE MAL (FEI: 3015407053) has 1 FDA import refusal record(s) in our database, spanning from 7/2/2019 to 7/2/2019.

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. SULTANBEYLI BAHARAT AKTARIYE MAL's FEI number is 3015407053.

What types of violations has SULTANBEYLI BAHARAT AKTARIYE MAL received?

SULTANBEYLI BAHARAT AKTARIYE MAL 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 SULTANBEYLI BAHARAT AKTARIYE MAL come from?

All FDA import refusal data for SULTANBEYLI BAHARAT AKTARIYE MAL 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.