Brazil Prologic Comercio Exterior Ltda
⚠️ Moderate Risk
FEI: 3004288328 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3004288328
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Baronesa De Bela Vista 735 Cj 31, , Sao Paulo, 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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 Brazil Prologic Comercio Exterior Ltda's FDA import refusal history?
Brazil Prologic Comercio Exterior Ltda (FEI: 3004288328) has 2 FDA import refusal record(s) in our database, spanning from 11/2/2004 to 12/22/2004.
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. Brazil Prologic Comercio Exterior Ltda's FEI number is 3004288328.
What types of violations has Brazil Prologic Comercio Exterior Ltda received?
Brazil Prologic Comercio Exterior Ltda has been cited for 4 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 Brazil Prologic Comercio Exterior Ltda come from?
All FDA import refusal data for Brazil Prologic Comercio Exterior 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.