PROMARISCO S.A.
⚠️ Moderate Risk
FEI: 3009908739 • Guayaquil, Guayas • ECUADOR
FEI Number
3009908739
Location
Guayaquil, Guayas
Country
ECUADORAddress
Km 6.5 Via Duran Tambo, , Guayaquil, Guayas, 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.
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.
LACKS N/C
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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.
USUAL NAME
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2015 | 28FHT99MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C. | Philadelphia District Office (PHI-DO) | |
| 10/27/2015 | 28FHT99MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C. | Philadelphia District Office (PHI-DO) | |
| 10/27/2015 | 28FHT99MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C. | Philadelphia District Office (PHI-DO) | |
| 10/27/2015 | 28FHT99MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C. | Philadelphia District Office (PHI-DO) | |
| 9/30/2015 | 30GDT99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Philadelphia District Office (PHI-DO) | |
| 9/30/2015 | 30GDT99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Philadelphia District Office (PHI-DO) | |
| 9/30/2015 | 30GDT99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | Philadelphia District Office (PHI-DO) | |
| 4/8/2011 | 41YGH99DIETARY CONVENTIONAL FOODS, N.E.C. | New York District Office (NYK-DO) | |
| 4/9/2010 | 16JGC05SHRIMP & PRAWNS | 9SALMONELLA | New York District Office (NYK-DO) |
| 12/17/2009 | 16JGC05SHRIMP & PRAWNS | 9SALMONELLA | New York District Office (NYK-DO) |
| 11/18/2009 | 16JGC05SHRIMP & PRAWNS | New York District Office (NYK-DO) | |
| 11/17/2008 | 02EGH99WHEAT FLOUR, N.E.C. | Chicago District Office (CHI-DO) | |
| 6/24/2008 | 16JGD05SHRIMP & PRAWNS | 249FILTHY | New York District Office (NYK-DO) |
| 2/14/2002 | 16JGT05SHRIMP & PRAWNS | 9SALMONELLA | Baltimore District Office (BLT-DO) |
| 12/27/2001 | 16KGT05SHRIMP & PRAWNS, BREADED | 9SALMONELLA | New York District Office (NYK-DO) |
Frequently Asked Questions
What is PROMARISCO S.A.'s FDA import refusal history?
PROMARISCO S.A. (FEI: 3009908739) has 15 FDA import refusal record(s) in our database, spanning from 12/27/2001 to 10/27/2015.
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. PROMARISCO S.A.'s FEI number is 3009908739.
What types of violations has PROMARISCO S.A. received?
PROMARISCO S.A. has been cited for 8 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 PROMARISCO S.A. come from?
All FDA import refusal data for PROMARISCO 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.