THEMRA BITKISEL
⚠️ Moderate Risk
FEI: 3021928966 • Mersin • TURKEY
FEI Number
3021928966
Location
Mersin
Country
TURKEYAddress
Toptancilar Sitesi Z Blok No: 29-30-31 Akdeniz Hal Mah. T. Zal Bulv.No:24 Yeni Hal Kompleksi, , Mersin, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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
Frequently Asked Questions
What is THEMRA BITKISEL's FDA import refusal history?
THEMRA BITKISEL (FEI: 3021928966) has 1 FDA import refusal record(s) in our database, spanning from 5/24/2022 to 5/24/2022.
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. THEMRA BITKISEL's FEI number is 3021928966.
What types of violations has THEMRA BITKISEL received?
THEMRA BITKISEL 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 THEMRA BITKISEL come from?
All FDA import refusal data for THEMRA BITKISEL 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.