Taro Pharmaceutical Industries Ltd.
⚠️ High Risk
FEI: 3002808385 • Haifa • ISRAEL
FEI Number
3002808385
Location
Haifa
Country
ISRAELAddress
Haifa Bay, 14, Ha-Kitor, Haifa, , 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2025 | 62GCY91ETODOLAC (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 1/4/2017 | 62LCL40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Northeast Imports (DNEI) | |
| 1/4/2017 | 62LCL40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Northeast Imports (DNEI) | |
| 1/4/2017 | 62LCL40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Northeast Imports (DNEI) | |
| 1/4/2017 | 62LCL40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Northeast Imports (DNEI) | |
| 8/12/2016 | 63DDB01ACETAZOLAMIDE (CARBONIC ANHYDRASE INHIBITOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/27/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 7/9/2014 | 63JCS99CHELATING AGENT N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/14/2012 | 63DCA01ACETAZOLAMIDE (CARBONIC ANHYDRASE INHIBITOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/15/2011 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/6/2010 | 62GCL16DESONIDE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/22/2008 | 64TCJ08TACROLIMUS (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/22/2008 | 64TCJ08TACROLIMUS (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/16/2006 | 65VCA56ZOLPIDEM TARTRATE (SEDATIVE) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/7/2006 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New York District Office (NYK-DO) | |
| 7/7/2006 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New York District Office (NYK-DO) | |
| 7/7/2006 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New York District Office (NYK-DO) | |
| 7/7/2006 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | New York District Office (NYK-DO) | |
| 3/15/2005 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 10/18/2004 | 61NCL69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Taro Pharmaceutical Industries Ltd.'s FDA import refusal history?
Taro Pharmaceutical Industries Ltd. (FEI: 3002808385) has 20 FDA import refusal record(s) in our database, spanning from 10/18/2004 to 8/1/2025.
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. Taro Pharmaceutical Industries Ltd.'s FEI number is 3002808385.
What types of violations has Taro Pharmaceutical Industries Ltd. received?
Taro Pharmaceutical Industries Ltd. has been cited for 3 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 Taro Pharmaceutical Industries Ltd. come from?
All FDA import refusal data for Taro 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.