FARMACEUTICA PARAGUAYA SA
⚠️ High Risk
FEI: 3013723403 • Fernando De La Mora, Central • PARAGUAY
FEI Number
3013723403
Location
Fernando De La Mora, Central
Country
PARAGUAYAddress
Waldino R Lovera Esq De, , Fernando De La Mora, Central, Paraguay
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is FARMACEUTICA PARAGUAYA SA's FDA import refusal history?
FARMACEUTICA PARAGUAYA SA (FEI: 3013723403) has 2 FDA import refusal record(s) in our database, spanning from 9/19/2017 to 5/22/2024.
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. FARMACEUTICA PARAGUAYA SA's FEI number is 3013723403.
What types of violations has FARMACEUTICA PARAGUAYA SA received?
FARMACEUTICA PARAGUAYA SA 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 FARMACEUTICA PARAGUAYA SA come from?
All FDA import refusal data for FARMACEUTICA PARAGUAYA SA 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.