Recalcine Labs Sa
⚠️ High Risk
FEI: 3007562185 • Santiago • CHILE
FEI Number
3007562185
Location
Santiago
Country
CHILEAddress
Avenida Carrascal 5650, , Santiago, , Chile
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 Recalcine Labs Sa's FDA import refusal history?
Recalcine Labs Sa (FEI: 3007562185) has 2 FDA import refusal record(s) in our database, spanning from 5/6/2015 to 1/9/2026.
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. Recalcine Labs Sa's FEI number is 3007562185.
What types of violations has Recalcine Labs Sa received?
Recalcine Labs 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 Recalcine Labs Sa come from?
All FDA import refusal data for Recalcine Labs 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.