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Abbott Pharmaceuticals

⚠️ Moderate Risk

FEI: 3007702682 • Cranbury, NJ • UNITED STATES

FEI

FEI Number

3007702682

📍

Location

Cranbury, NJ

🇺🇸
🏢

Address

1 Cedarbrook Dr, , Cranbury, NJ, United States

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/21/2009
Latest Refusal
8/21/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1792×

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
8/21/2009
61MDA35DIVALPROEX SODIUM (ANTI-CONVULSANT)
179AGR RX
Southwest Import District Office (SWI-DO)
8/21/2009
56IDL25ERYTHROMYCIN ETHYLSUCCINATE (MACROLIDES)
179AGR RX
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Abbott Pharmaceuticals's FDA import refusal history?

Abbott Pharmaceuticals (FEI: 3007702682) has 2 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 8/21/2009.

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. Abbott Pharmaceuticals's FEI number is 3007702682.

What types of violations has Abbott Pharmaceuticals received?

Abbott Pharmaceuticals 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 Abbott Pharmaceuticals come from?

All FDA import refusal data for Abbott 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.