Laboratorios Lufra Farmacos S.A.
⚠️ Moderate Risk
FEI: 3000596547 • Santa Domingo • DOMINICAN REPUBLIC
FEI Number
3000596547
Location
Santa Domingo
Country
DOMINICAN REPUBLICAddress
unknown, , Santa Domingo, , Dominican Republic
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Laboratorios Lufra Farmacos S.A.'s FDA import refusal history?
Laboratorios Lufra Farmacos S.A. (FEI: 3000596547) has 2 FDA import refusal record(s) in our database, spanning from 8/1/2012 to 8/1/2012.
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 Lufra Farmacos S.A.'s FEI number is 3000596547.
What types of violations has Laboratorios Lufra Farmacos S.A. received?
Laboratorios Lufra Farmacos S.A. has been cited for 3 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 Lufra Farmacos S.A. come from?
All FDA import refusal data for Laboratorios 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.