Envasados Comestibles, S.A. (ENCOSA)
⚠️ Moderate Risk
FEI: 3004309692 • Santo Domingo, Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3004309692
Location
Santo Domingo, Santo Domingo
Country
DOMINICAN REPUBLICAddress
Zona Industrial Los Alcarrizos, Manzana C. No. 8, Santo Domingo, Santo Domingo, Dominican Republic
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
NONRSP-VER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this thermally processed low acid food packaged in a hermetically sealed container pursuant to 21 CFR 108.35 (c)(2) appears to be inadequate to protect the public 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
Frequently Asked Questions
What is Envasados Comestibles, S.A. (ENCOSA)'s FDA import refusal history?
Envasados Comestibles, S.A. (ENCOSA) (FEI: 3004309692) has 2 FDA import refusal record(s) in our database, spanning from 2/1/2012 to 5/10/2013.
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. Envasados Comestibles, S.A. (ENCOSA)'s FEI number is 3004309692.
What types of violations has Envasados Comestibles, S.A. (ENCOSA) received?
Envasados Comestibles, S.A. (ENCOSA) has been cited for 2 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 Envasados Comestibles, S.A. (ENCOSA) come from?
All FDA import refusal data for Envasados Comestibles, S.A. (ENCOSA) 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.