Teva Pharmaceuticals Polska
⚠️ Moderate Risk
FEI: 3008815336 • Warszawa, Mazowieckie • POLAND
FEI Number
3008815336
Location
Warszawa, Mazowieckie
Country
POLANDAddress
Ul Emilii Plater 53, , Warszawa, Mazowieckie, Poland
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2022 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2022 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2012 | 61TBA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Teva Pharmaceuticals Polska's FDA import refusal history?
Teva Pharmaceuticals Polska (FEI: 3008815336) has 3 FDA import refusal record(s) in our database, spanning from 2/22/2012 to 10/21/2022.
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 Polska's FEI number is 3008815336.
What types of violations has Teva Pharmaceuticals Polska received?
Teva Pharmaceuticals Polska 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 Polska come from?
All FDA import refusal data for Teva Pharmaceuticals Polska 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.