Teva Pharmaceuticals USA, Inc
⚠️ High Risk
FEI: 3003092769 • Parsippany, NJ • UNITED STATES
FEI Number
3003092769
Location
Parsippany, NJ
Country
UNITED STATESAddress
400 Interpace Pkwy Bldg A, , Parsippany, NJ, United States
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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2024 | 66MCY09BUSPIRONE HCL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2024 | 56IDA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 56BDH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 62LDA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 56BDH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 9/9/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2019 | 61LCA13WARFARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/15/2018 | 56ECY80TETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2016 | 66NDY06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 179AGR RX | New York District Office (NYK-DO) |
| 8/16/2016 | 61NDY60TRAZODONE HCL (ANTI-DEPRESSANT) | 179AGR RX | New York District Office (NYK-DO) |
| 6/10/2015 | 60LDA83CELECOXIB (ANALGESIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 6/10/2015 | 63ADA02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 64LCO28FLUOCINONIDE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 56CCH73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 61WCO47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 62LCA50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 62KCH08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 61FCH30DICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/11/2012 | 62CCH47PRAZOSIN HCL (ANTI-HYPERTENSIVE) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/21/2009 | 62VDH18ACYCLOVIR (ANTI-VIRAL) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 60LDA14CARBAMAZEPINE (ANALGESIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 8/21/2009 | 62IDA30MERCAPTOPURINE (ANTI-NEOPLASTIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Teva Pharmaceuticals USA, Inc's FDA import refusal history?
Teva Pharmaceuticals USA, Inc (FEI: 3003092769) has 25 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 5/21/2024.
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 Pharmaceuticals USA, Inc's FEI number is 3003092769.
What types of violations has Teva Pharmaceuticals USA, Inc received?
Teva Pharmaceuticals USA, Inc 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 Pharmaceuticals USA, Inc come from?
All FDA import refusal data for Teva Pharmaceuticals USA, Inc 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.