Pharmeks Dis Ticaret Ltd Sti
⚠️ Moderate Risk
FEI: 3007056005 • Istanbul • TURKEY
FEI Number
3007056005
Location
Istanbul
Country
TURKEYAddress
Istoc 29 Ada No 110, , 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 |
|---|---|---|---|
| 1/5/2011 | 62TDA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2011 | 62TDA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2011 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 1/5/2011 | 61GCL80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharmeks Dis Ticaret Ltd Sti's FDA import refusal history?
Pharmeks Dis Ticaret Ltd Sti (FEI: 3007056005) has 4 FDA import refusal record(s) in our database, spanning from 1/5/2011 to 1/5/2011.
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. Pharmeks Dis Ticaret Ltd Sti's FEI number is 3007056005.
What types of violations has Pharmeks Dis Ticaret Ltd Sti received?
Pharmeks Dis Ticaret Ltd Sti 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 Pharmeks Dis Ticaret Ltd Sti come from?
All FDA import refusal data for Pharmeks Dis Ticaret 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.