Fmcg Dis Tic
⚠️ Moderate Risk
FEI: 3009321553 • Istanbul • TURKEY
FEI Number
3009321553
Location
Istanbul
Country
TURKEYAddress
Istanbul Deri Ve Endustri Serbest, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 4/2/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/2/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/2/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/2/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/19/2012 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 8/16/2012 | 53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/12/2012 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | New York District Office (NYK-DO) |
| 6/27/2012 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 6/27/2012 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 6/27/2012 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 6/27/2012 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Fmcg Dis Tic's FDA import refusal history?
Fmcg Dis Tic (FEI: 3009321553) has 11 FDA import refusal record(s) in our database, spanning from 6/27/2012 to 4/2/2013.
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. Fmcg Dis Tic's FEI number is 3009321553.
What types of violations has Fmcg Dis Tic received?
Fmcg Dis Tic has been cited for 6 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 Fmcg Dis Tic come from?
All FDA import refusal data for Fmcg 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.