Pce Import Com. Manut Mat Cirurgtco
⚠️ Moderate Risk
FEI: 3005257879 • Sao Paulo, SP • BRAZIL
FEI Number
3005257879
Location
Sao Paulo, SP
Country
BRAZILAddress
Rua Itapiru 137, , Sao Paulo, SP, 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).
Refusal History
Frequently Asked Questions
What is Pce Import Com. Manut Mat Cirurgtco's FDA import refusal history?
Pce Import Com. Manut Mat Cirurgtco (FEI: 3005257879) has 2 FDA import refusal record(s) in our database, spanning from 12/5/2009 to 12/5/2009.
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. Pce Import Com. Manut Mat Cirurgtco's FEI number is 3005257879.
What types of violations has Pce Import Com. Manut Mat Cirurgtco received?
Pce Import Com. Manut Mat Cirurgtco 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 Pce Import Com. Manut Mat Cirurgtco come from?
All FDA import refusal data for Pce Import Com. Manut Mat Cirurgtco 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.