biometil laboratorio
⚠️ Moderate Risk
FEI: 3017571232 • Sao Bento Do Sul, SC • BRAZIL
FEI Number
3017571232
Location
Sao Bento Do Sul, SC
Country
BRAZILAddress
Rua Joao Malinowsky, , Sao Bento Do Sul, SC, Brazil
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is biometil laboratorio's FDA import refusal history?
biometil laboratorio (FEI: 3017571232) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2025 to 9/30/2025.
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. biometil laboratorio's FEI number is 3017571232.
What types of violations has biometil laboratorio received?
biometil laboratorio has been cited for 2 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 biometil laboratorio come from?
All FDA import refusal data for biometil laboratorio 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.