HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI
⚠️ Moderate Risk
FEI: 3013402552 • Pendik, Istanbul • TURKEY
FEI Number
3013402552
Location
Pendik, Istanbul
Country
TURKEYAddress
Fevzi Cakmak Mah, Zonduldak Sok No 22a, Pendik, 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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
708UDECAPI
The article has been determined to contain an API that is undeclared on the label or accompanying labeling.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2019 | 66BCY99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2019 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/17/2018 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/17/2018 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/17/2018 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 12/14/2018 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/7/2018 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI's FDA import refusal history?
HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI (FEI: 3013402552) has 7 FDA import refusal record(s) in our database, spanning from 12/7/2018 to 3/20/2019.
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. HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI's FEI number is 3013402552.
What types of violations has HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI received?
HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI 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 HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI come from?
All FDA import refusal data for HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI 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.