Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S.
⚠️ Moderate Risk
FEI: 1000617211 • 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S.'s FDA import refusal history?
Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S. (FEI: 1000617211) has 2 FDA import refusal record(s) in our database, spanning from 7/20/2005 to 6/24/2025.
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. Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S.'s FEI number is 1000617211.
What types of violations has Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S. received?
Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S. 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 Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S. come from?
All FDA import refusal data for Abbott Laboraturlari Ithalat Ihracat Ve Ticaret A.S. 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.