Frine Hernandez De Salazar
⚠️ Moderate Risk
FEI: 3003866029 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC
FEI Number
3003866029
Location
Santo Domingo De Guzman, Distrito Nacional
Country
DOMINICAN REPUBLICAddress
Camino Del Trebid # 7, , Santo Domingo De Guzman, Distrito Nacional, 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
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is Frine Hernandez De Salazar's FDA import refusal history?
Frine Hernandez De Salazar (FEI: 3003866029) has 1 FDA import refusal record(s) in our database, spanning from 2/19/2003 to 2/19/2003.
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. Frine Hernandez De Salazar's FEI number is 3003866029.
What types of violations has Frine Hernandez De Salazar received?
Frine Hernandez De Salazar 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 Frine Hernandez De Salazar come from?
All FDA import refusal data for Frine Hernandez De Salazar 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.