Teva Pharmaceutical Industries, LTD.
⚠️ Moderate Risk
FEI: 3002874027 • Petakh Tikva • ISRAEL
FEI Number
3002874027
Location
Petakh Tikva
Country
ISRAELAddress
5, Basel, , Petakh Tikva, , 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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2018 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2018 | 62ODY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/30/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2017 | 61LDY13WARFARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2017 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2017 | 61PDB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/29/2015 | 66JAB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/29/2015 | 65RCA14POTASSIUM CHLORIDE (REPLENISHER) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/29/2015 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/29/2015 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/23/2014 | 61JCB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/1/2011 | 61LCS39BIVALIRUDIN (ANTI-COAGULANT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/1/2011 | 61LCS39BIVALIRUDIN (ANTI-COAGULANT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/7/2011 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/10/2009 | 61NCS69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/10/2009 | 61NCS69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/10/2009 | 61NCS69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/29/2009 | 62VCS42VALACYCLOVIR HCL (ANTI-VIRAL) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 10/29/2009 | 62VCS42VALACYCLOVIR HCL (ANTI-VIRAL) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 10/29/2009 | 62VCS42VALACYCLOVIR HCL (ANTI-VIRAL) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 10/29/2009 | 62VCS42VALACYCLOVIR HCL (ANTI-VIRAL) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 10/29/2009 | 62VCS42VALACYCLOVIR HCL (ANTI-VIRAL) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 12/27/2007 | 61NDY29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/21/2004 | 60CDK46NAPHAZOLINE HCL (ADRENERGIC) | New Orleans District Office (NOL-DO) | |
| 5/3/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/3/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Teva Pharmaceutical Industries, LTD.'s FDA import refusal history?
Teva Pharmaceutical Industries, LTD. (FEI: 3002874027) has 26 FDA import refusal record(s) in our database, spanning from 5/3/2004 to 7/9/2018.
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 3002874027.
What types of violations has Teva Pharmaceutical Industries, LTD. received?
Teva Pharmaceutical Industries, LTD. has been cited for 5 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.