MM Optics LTDA
⚠️ Moderate Risk
FEI: 3004057576 • Sao Carlos, Sao Paulo • BRAZIL
FEI Number
3004057576
Location
Sao Carlos, Sao Paulo
Country
BRAZILAddress
Rua Geminiano Costa, 143, , Sao Carlos, Sao Paulo, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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 MM Optics LTDA's FDA import refusal history?
MM Optics LTDA (FEI: 3004057576) has 1 FDA import refusal record(s) in our database, spanning from 7/8/2003 to 7/8/2003.
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. MM Optics LTDA's FEI number is 3004057576.
What types of violations has MM Optics LTDA received?
MM Optics LTDA 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 MM Optics LTDA come from?
All FDA import refusal data for MM Optics LTDA 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.