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ABBOTT LABORATORIES DE CHILE LTDA.

⚠️ Moderate Risk

FEI: 3014314898 • Santiago • CHILE

FEI

FEI Number

3014314898

📍

Location

Santiago

🇨🇱

Country

CHILE
🏢

Address

Avenida El Salto 5380, , Santiago, , Chile

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
1/10/2020
Latest Refusal
1/10/2020
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
1/10/2020
61NDY78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ABBOTT LABORATORIES DE CHILE LTDA.'s FDA import refusal history?

ABBOTT LABORATORIES DE CHILE LTDA. (FEI: 3014314898) has 1 FDA import refusal record(s) in our database, spanning from 1/10/2020 to 1/10/2020.

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 DE CHILE LTDA.'s FEI number is 3014314898.

What types of violations has ABBOTT LABORATORIES DE CHILE LTDA. received?

ABBOTT LABORATORIES DE CHILE LTDA. 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 DE CHILE LTDA. come from?

All FDA import refusal data for ABBOTT LABORATORIES DE CHILE LTDA. 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.