TEVA PHARMACEUTICAL INDUSTRIES LTD.
⚠️ Moderate Risk
FEI: 3018101289 • Tel Aviv-Yafo • ISRAEL
FEI Number
3018101289
Location
Tel Aviv-Yafo
Country
ISRAELAddress
124, Dvora Ha-Nevi'A, , Tel Aviv-Yafo, , Israel
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 TEVA PHARMACEUTICAL INDUSTRIES LTD.'s FDA import refusal history?
TEVA PHARMACEUTICAL INDUSTRIES LTD. (FEI: 3018101289) has 2 FDA import refusal record(s) in our database, spanning from 6/8/2021 to 12/23/2024.
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. TEVA PHARMACEUTICAL INDUSTRIES LTD.'s FEI number is 3018101289.
What types of violations has TEVA PHARMACEUTICAL INDUSTRIES LTD. received?
TEVA PHARMACEUTICAL INDUSTRIES LTD. 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 TEVA PHARMACEUTICAL INDUSTRIES LTD. come from?
All FDA import refusal data for TEVA PHARMACEUTICAL INDUSTRIES LTD. 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.