Congebras Alimentos Ltda.
⚠️ Moderate Risk
FEI: 2000006443 • Belo Horizonte, Minas Gerais • BRAZIL
FEI Number
2000006443
Location
Belo Horizonte, Minas Gerais
Country
BRAZILAddress
Rua Dos Guajajaras, 870 11 Floor, , Belo Horizonte, Minas Gerais, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
Frequently Asked Questions
What is Congebras Alimentos Ltda.'s FDA import refusal history?
Congebras Alimentos Ltda. (FEI: 2000006443) has 2 FDA import refusal record(s) in our database, spanning from 5/1/2007 to 2/18/2010.
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. Congebras Alimentos Ltda.'s FEI number is 2000006443.
What types of violations has Congebras Alimentos Ltda. received?
Congebras Alimentos Ltda. has been cited for 3 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 Congebras Alimentos Ltda. come from?
All FDA import refusal data for Congebras Alimentos 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.