Alcon Lab Do Brasi
⚠️ Moderate Risk
FEI: 3004742481 • Sao Paulo • BRAZIL
FEI Number
3004742481
Location
Sao Paulo
Country
BRAZILAddress
Av Nossa Sennnhora Da, , 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
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).
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 Alcon Lab Do Brasi's FDA import refusal history?
Alcon Lab Do Brasi (FEI: 3004742481) has 2 FDA import refusal record(s) in our database, spanning from 12/10/2007 to 6/11/2012.
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. Alcon Lab Do Brasi's FEI number is 3004742481.
What types of violations has Alcon Lab Do Brasi received?
Alcon Lab Do Brasi 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 Alcon Lab Do Brasi come from?
All FDA import refusal data for Alcon Lab Do Brasi 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.