Fuxion Biotech S.A.C.
⚠️ High Risk
FEI: 3015216742 • Lurin, Lima • PERU
FEI Number
3015216742
Location
Lurin, Lima
Country
PERUAddress
Calle Los Eucaliptos Lt 1 C2, Urb Sta Genoveva, Lurin, Lima, Peru
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 Fuxion Biotech S.A.C.'s FDA import refusal history?
Fuxion Biotech S.A.C. (FEI: 3015216742) has 2 FDA import refusal record(s) in our database, spanning from 1/24/2025 to 1/24/2025.
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. Fuxion Biotech S.A.C.'s FEI number is 3015216742.
What types of violations has Fuxion Biotech S.A.C. received?
Fuxion Biotech S.A.C. 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 Fuxion Biotech S.A.C. come from?
All FDA import refusal data for Fuxion Biotech S.A.C. 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.