ImportRefusal LogoImportRefusal

Lufra Farmacos S.A.

⚠️ Moderate Risk

FEI: 3004462768 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC

FEI

FEI Number

3004462768

📍

Location

Santo Domingo De Guzman, Distrito Nacional

🇩🇴
🏢

Address

Unknown Street, , Santo Domingo De Guzman, Distrito Nacional, Dominican Republic

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
2
Unique Violations
12/21/2011
Latest Refusal
12/21/2011
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
12/21/2011
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
12/21/2011
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Lufra Farmacos S.A.'s FDA import refusal history?

Lufra Farmacos S.A. (FEI: 3004462768) has 2 FDA import refusal record(s) in our database, spanning from 12/21/2011 to 12/21/2011.

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. Lufra Farmacos S.A.'s FEI number is 3004462768.

What types of violations has Lufra Farmacos S.A. received?

Lufra Farmacos S.A. 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 Lufra Farmacos S.A. come from?

All FDA import refusal data for Lufra Farmacos S.A. 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.