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Laboratorio Clinico Alcantavava

✅ Low Risk

FEI: 3004631883 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3004631883

📍

Location

Santo Domingo

🇩🇴
🏢

Address

Alexsandvs Flemins 75, , Santo Domingo, , Dominican Republic

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
8/31/2004
Latest Refusal
8/31/2004
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
8/31/2004
75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
333LACKS FIRM
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratorio Clinico Alcantavava's FDA import refusal history?

Laboratorio Clinico Alcantavava (FEI: 3004631883) has 1 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 8/31/2004.

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. Laboratorio Clinico Alcantavava's FEI number is 3004631883.

What types of violations has Laboratorio Clinico Alcantavava received?

Laboratorio Clinico Alcantavava has been cited for 2 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 Laboratorio Clinico Alcantavava come from?

All FDA import refusal data for Laboratorio Clinico Alcantavava 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.