Hermes Eczanesi Cagri Komsoken
⚠️ Moderate Risk
FEI: 3010201592 • Istanbul • TURKEY
FEI Number
3010201592
Location
Istanbul
Country
TURKEYAddress
Abide-1 Hurriyet Cad, , 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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/28/2017 | 62IDY86LEUPROLIDE ACETATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2013 | 64MCP13CETRORELIX ACETATE (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) | |
| 11/7/2013 | 64MCP10UROFOLLITROPIN (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hermes Eczanesi Cagri Komsoken's FDA import refusal history?
Hermes Eczanesi Cagri Komsoken (FEI: 3010201592) has 3 FDA import refusal record(s) in our database, spanning from 11/7/2013 to 6/28/2017.
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. Hermes Eczanesi Cagri Komsoken's FEI number is 3010201592.
What types of violations has Hermes Eczanesi Cagri Komsoken received?
Hermes Eczanesi Cagri Komsoken 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 Hermes Eczanesi Cagri Komsoken come from?
All FDA import refusal data for Hermes Eczanesi Cagri Komsoken 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.