Productos Del Mar S.A. (Promasa)
⚠️ Moderate Risk
FEI: 8873 • Manta, Manabi • ECUADOR
FEI Number
8873
Location
Manta, Manabi
Country
ECUADORAddress
Ave. 102 Str. 120, , Manta, Manabi, 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
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.
HISTAMINE
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.
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 |
|---|---|---|---|
| 12/17/2007 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 7/13/2007 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | Los Angeles District Office (LOS-DO) | |
| 8/1/2006 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 249FILTHY | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Productos Del Mar S.A. (Promasa)'s FDA import refusal history?
Productos Del Mar S.A. (Promasa) (FEI: 8873) has 3 FDA import refusal record(s) in our database, spanning from 8/1/2006 to 12/17/2007.
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. Productos Del Mar S.A. (Promasa)'s FEI number is 8873.
What types of violations has Productos Del Mar S.A. (Promasa) received?
Productos Del Mar S.A. (Promasa) 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 Productos Del Mar S.A. (Promasa) come from?
All FDA import refusal data for Productos Del Mar S.A. (Promasa) 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.