Produsa S.A.
⚠️ Moderate Risk
FEI: 1000310859 • Guayquil • ECUADOR
FEI Number
1000310859
Location
Guayquil
Country
ECUADORAddress
Baquerizo Moreno 1119, , Guayquil, , Ecuador
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
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/7/2008 | 12CGO13CHEESE, HISPANIC/LATINO/MEXICAN STYLE, ALL VARIETIES, INCLUDING QUESO | 308MFR INSAN | New York District Office (NYK-DO) |
| 10/28/2004 | 24FCE08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE) | New York District Office (NYK-DO) | |
| 9/15/2004 | 02GGT99FLOURS AND MEALS N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 2/23/2003 | 24ACT99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | New York District Office (NYK-DO) | |
| 10/16/2002 | 17BGT09PHEASANT | 9SALMONELLA | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Produsa S.A.'s FDA import refusal history?
Produsa S.A. (FEI: 1000310859) has 5 FDA import refusal record(s) in our database, spanning from 10/16/2002 to 2/7/2008.
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. Produsa S.A.'s FEI number is 1000310859.
What types of violations has Produsa S.A. received?
Produsa S.A. has been cited for 5 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 Produsa S.A. come from?
All FDA import refusal data for Produsa S.A. 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.