Teva Pharmaceu
⚠️ Moderate Risk
FEI: 3002822816 • Petah Tikva • ISRAEL
FEI Number
3002822816
Location
Petah Tikva
Country
ISRAELAddress
16 Basel St, , Petah 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/5/2009 | 62VCS25FAMCICLOVIR (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/23/2007 | 61NCF69GABAPENTIN (ANTI-DEPRESSANT) | New Orleans District Office (NOL-DO) | |
| 2/25/2004 | 56ICB76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Teva Pharmaceu's FDA import refusal history?
Teva Pharmaceu (FEI: 3002822816) has 4 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 6/5/2009.
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 Pharmaceu's FEI number is 3002822816.
What types of violations has Teva Pharmaceu received?
Teva Pharmaceu 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 Pharmaceu come from?
All FDA import refusal data for Teva Pharmaceu 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.