LABORATORIOS SHOLLER
⚠️ Moderate Risk
FEI: 3021782836 • San Jose • COSTA RICA
FEI Number
3021782836
Location
San Jose
Country
COSTA RICAAddress
Los Yoses, , San Jose, , Costa Rica
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
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 LABORATORIOS SHOLLER's FDA import refusal history?
LABORATORIOS SHOLLER (FEI: 3021782836) has 3 FDA import refusal record(s) in our database, spanning from 3/30/2022 to 3/30/2022.
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. LABORATORIOS SHOLLER's FEI number is 3021782836.
What types of violations has LABORATORIOS SHOLLER received?
LABORATORIOS SHOLLER 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 LABORATORIOS SHOLLER come from?
All FDA import refusal data for LABORATORIOS SHOLLER 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.