ImportRefusal LogoImportRefusal

Teva Pharmaceuticals USA dba Copley Manufacturing

⚠️ Moderate Risk

FEI: 1250024 • South Boston, MA • UNITED STATES

FEI

FEI Number

1250024

📍

Location

South Boston, MA

🇺🇸
🏢

Address

79 Dresser St, , South Boston, MA, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/16/2004
Latest Refusal
12/16/2004
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1791×

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

DateProductViolationsDivision
12/16/2004
61PCC55METFORMIN HCL (ANTI-DIABETIC)
179AGR RX
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Teva Pharmaceuticals USA dba Copley Manufacturing's FDA import refusal history?

Teva Pharmaceuticals USA dba Copley Manufacturing (FEI: 1250024) has 1 FDA import refusal record(s) in our database, spanning from 12/16/2004 to 12/16/2004.

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 dba Copley Manufacturing's FEI number is 1250024.

What types of violations has Teva Pharmaceuticals USA dba Copley Manufacturing received?

Teva Pharmaceuticals USA dba Copley Manufacturing has been cited for 1 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 dba Copley Manufacturing come from?

All FDA import refusal data for Teva Pharmaceuticals USA dba Copley Manufacturing 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.