Laboratorios Portugal
⚠️ Moderate Risk
FEI: 3004635339 • Lima, Lima • PERU
FEI Number
3004635339
Location
Lima, Lima
Country
PERUAddress
Calle San Miguel 213, , Lima, Lima, Peru
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
Frequently Asked Questions
What is Laboratorios Portugal's FDA import refusal history?
Laboratorios Portugal (FEI: 3004635339) has 2 FDA import refusal record(s) in our database, spanning from 9/7/2012 to 9/7/2012.
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 Portugal's FEI number is 3004635339.
What types of violations has Laboratorios Portugal received?
Laboratorios Portugal 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 Portugal come from?
All FDA import refusal data for Laboratorios Portugal 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.