Com E Dist Modolo Ltda
⚠️ Moderate Risk
FEI: 3002530298 • Piqueri • BRAZIL
FEI Number
3002530298
Location
Piqueri
Country
BRAZILAddress
Rua Manoel De Carvalho 414, , Piqueri, , 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).
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).
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2003 | 60SAL11MAGNESIA (ANTACID) | New York District Office (NYK-DO) | |
| 5/7/2003 | 60SAL11MAGNESIA (ANTACID) | New York District Office (NYK-DO) | |
| 4/24/2002 | 24TET39HEART OF PALM (LEAF & STEM VEGETABLE) | New York District Office (NYK-DO) | |
| 4/24/2002 | 24TET39HEART OF PALM (LEAF & STEM VEGETABLE) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Com E Dist Modolo Ltda's FDA import refusal history?
Com E Dist Modolo Ltda (FEI: 3002530298) has 4 FDA import refusal record(s) in our database, spanning from 4/24/2002 to 6/13/2003.
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. Com E Dist Modolo Ltda's FEI number is 3002530298.
What types of violations has Com E Dist Modolo Ltda received?
Com E Dist Modolo 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 Com E Dist Modolo Ltda come from?
All FDA import refusal data for Com E Dist Modolo 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.