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Laboratorios Alfa SRL

⚠️ Moderate Risk

FEI: 3001195282 • Santo Domingo Oeste • DOMINICAN REPUBLIC

FEI

FEI Number

3001195282

📍

Location

Santo Domingo Oeste

🇩🇴
🏢

Address

Av. Republica De Colombia Km 13, , Santo Domingo Oeste, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/29/2020
Latest Refusal
10/15/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
12/29/2020
62LCY47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/6/2020
62LDB47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/15/2020
54YMR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Laboratorios Alfa SRL's FDA import refusal history?

Laboratorios Alfa SRL (FEI: 3001195282) has 3 FDA import refusal record(s) in our database, spanning from 10/15/2020 to 12/29/2020.

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. Laboratorios Alfa SRL's FEI number is 3001195282.

What types of violations has Laboratorios Alfa SRL received?

Laboratorios Alfa SRL 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 Laboratorios Alfa SRL come from?

All FDA import refusal data for Laboratorios Alfa SRL 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.