Teva Pharmaceutical Industries Ltd.
⚠️ High Risk
FEI: 3002721084 • Kfar Saba • ISRAEL
FEI Number
3002721084
Location
Kfar Saba
Country
ISRAELAddress
18 Eli Hurvitz Street, Industrial Zone, , Kfar Saba, , Israel
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2023 | 62WBY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 62WBY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/9/2023 | 62WBY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2016 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 472NO ENGLISH | Philadelphia District Office (PHI-DO) |
| 7/20/2016 | 61EIP99ANTI-ASTHMATIC, N.E.C. | 472NO ENGLISH | Philadelphia District Office (PHI-DO) |
| 9/30/2013 | 64ACH04CLOROPHENE (DISINFECTANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/30/2013 | 65ACH04MEMANTINE HCI | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/30/2013 | 65ACH04MEMANTINE HCI | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/30/2013 | 65ACH04MEMANTINE HCI | 179AGR RX | New Orleans District Office (NOL-DO) |
| 12/9/2011 | 66VIE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/7/2011 | 62VDA42VALACYCLOVIR HCL (ANTI-VIRAL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/7/2011 | 62VDA42VALACYCLOVIR HCL (ANTI-VIRAL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/12/2009 | 64TDP02GLATIRAMER ACETATE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/22/2008 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/21/2004 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Teva Pharmaceutical Industries Ltd.'s FDA import refusal history?
Teva Pharmaceutical Industries Ltd. (FEI: 3002721084) has 15 FDA import refusal record(s) in our database, spanning from 9/21/2004 to 11/9/2023.
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 3002721084.
What types of violations has Teva Pharmaceutical Industries Ltd. received?
Teva Pharmaceutical Industries Ltd. has been cited for 4 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.