Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals)
⚠️ Moderate Risk
FEI: 2434498 • Pomona, NY • UNITED STATES
FEI Number
2434498
Location
Pomona, NY
Country
UNITED STATESAddress
223 Quaker Rd, , Pomona, NY, 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
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).
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 |
|---|---|---|---|
| 4/25/2017 | 60LCY14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/25/2006 | 64GIA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 62OQY18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals)'s FDA import refusal history?
Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) (FEI: 2434498) has 3 FDA import refusal record(s) in our database, spanning from 9/15/2005 to 4/25/2017.
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. Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals)'s FEI number is 2434498.
What types of violations has Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) received?
Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) 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 Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) come from?
All FDA import refusal data for Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) 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.