El Gran Samaritano, S.A.
⚠️ Moderate Risk
FEI: 3004562488 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3004562488
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
#14 C/2da, Urb. La Ceiba, Altos De, , Santo 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).
Refusal History
Frequently Asked Questions
What is El Gran Samaritano, S.A.'s FDA import refusal history?
El Gran Samaritano, S.A. (FEI: 3004562488) has 2 FDA import refusal record(s) in our database, spanning from 1/14/2005 to 1/14/2005.
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. El Gran Samaritano, S.A.'s FEI number is 3004562488.
What types of violations has El Gran Samaritano, S.A. received?
El Gran Samaritano, S.A. 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 El Gran Samaritano, S.A. come from?
All FDA import refusal data for El Gran Samaritano, 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.