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Abbott Laboratories (Puerto Rico), Inc.

⚠️ Moderate Risk

FEI: 2630031 • San Juan, PR • UNITED STATES

FEI

FEI Number

2630031

📍

Location

San Juan, PR

🇺🇸
🏢

Address

9615 Ave Los Romeros Ste 700, , San Juan, PR, United States

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/7/2017
Latest Refusal
3/7/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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).

Refusal History

DateProductViolationsDivision
3/7/2017
61MCB41VALPROIC ACID (ANTI-CONVULSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Abbott Laboratories (Puerto Rico), Inc.'s FDA import refusal history?

Abbott Laboratories (Puerto Rico), Inc. (FEI: 2630031) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2017 to 3/7/2017.

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. Abbott Laboratories (Puerto Rico), Inc.'s FEI number is 2630031.

What types of violations has Abbott Laboratories (Puerto Rico), Inc. received?

Abbott Laboratories (Puerto Rico), Inc. 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 Laboratories (Puerto Rico), Inc. come from?

All FDA import refusal data for Abbott Laboratories (Puerto Rico), 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.