ESCUALEM S.A.
⚠️ Moderate Risk
FEI: 3009884398 • Guayaquil, Guayas • ECUADOR
FEI Number
3009884398
Location
Guayaquil, Guayas
Country
ECUADORAddress
Km 10.5 Via a Daule, Lotizacion Los Vergeles Mz 265 S/N, 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
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
MFRHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
HISTAMINE
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it 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.
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/28/2016 | 16AFD51MAHI MAHI | Division of Northeast Imports (DNEI) | |
| 4/15/2013 | 16AGC51MAHI MAHI | 2360HISTAMINE | Los Angeles District Office (LOS-DO) |
| 4/15/2013 | 16AGC42SWORDFISH | 251POISONOUS | Los Angeles District Office (LOS-DO) |
| 2/23/2011 | 16AGT54MARLIN | 306INSANITARY | Florida District Office (FLA-DO) |
| 9/17/2007 | 16AGC51MAHI MAHI | 2580MFRHACCP | Florida District Office (FLA-DO) |
| 8/13/2007 | 16AGC51MAHI MAHI | 2580MFRHACCP | Florida District Office (FLA-DO) |
| 8/13/2007 | 16AGC51MAHI MAHI | 2580MFRHACCP | Florida District Office (FLA-DO) |
| 6/14/2004 | 16AGC42SWORDFISH | 251POISONOUS | Florida District Office (FLA-DO) |
| 10/8/2003 | 16AGC42SWORDFISH | 251POISONOUS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is ESCUALEM S.A.'s FDA import refusal history?
ESCUALEM S.A. (FEI: 3009884398) has 9 FDA import refusal record(s) in our database, spanning from 10/8/2003 to 6/28/2016.
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. ESCUALEM S.A.'s FEI number is 3009884398.
What types of violations has ESCUALEM S.A. received?
ESCUALEM 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 ESCUALEM S.A. come from?
All FDA import refusal data for ESCUALEM 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.