GUCLU LTD VE DIS TIC
⚠️ Moderate Risk
FEI: 3019911355 • Kartal, Istanbul • TURKEY
FEI Number
3019911355
Location
Kartal, Istanbul
Country
TURKEYAddress
Cevizli Mahallesi, Bayraktar Sokak No 5-7, Kartal, Istanbul, Turkey
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2021 | 54YYY10ROYAL JELLY (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 11/30/2021 | 54YYY10ROYAL JELLY (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 11/30/2021 | 54YYY10ROYAL JELLY (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 11/9/2021 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is GUCLU LTD VE DIS TIC's FDA import refusal history?
GUCLU LTD VE DIS TIC (FEI: 3019911355) has 4 FDA import refusal record(s) in our database, spanning from 11/9/2021 to 11/30/2021.
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. GUCLU LTD VE DIS TIC's FEI number is 3019911355.
What types of violations has GUCLU LTD VE DIS TIC received?
GUCLU LTD VE DIS TIC has been cited for 2 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 GUCLU LTD VE DIS TIC come from?
All FDA import refusal data for GUCLU LTD VE DIS TIC 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.