Teva Parenteral Medicines, Inc.
⚠️ Moderate Risk
FEI: 2027158 • Irvine, CA • UNITED STATES
FEI Number
2027158
Location
Irvine, CA
Country
UNITED STATESAddress
19 Hughes, , Irvine, CA, United States
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
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article 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
Frequently Asked Questions
What is Teva Parenteral Medicines, Inc.'s FDA import refusal history?
Teva Parenteral Medicines, Inc. (FEI: 2027158) has 1 FDA import refusal record(s) in our database, spanning from 10/1/2014 to 10/1/2014.
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 Parenteral Medicines, Inc.'s FEI number is 2027158.
What types of violations has Teva Parenteral Medicines, Inc. received?
Teva Parenteral Medicines, 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 Parenteral Medicines, Inc. come from?
All FDA import refusal data for Teva Parenteral Medicines, 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.