Cesar Gaona Jaramillo
⚠️ High Risk
FEI: 3009709385 • Guayaquil, Guayas • ECUADOR
FEI Number
3009709385
Location
Guayaquil, Guayas
Country
ECUADORAddress
Cdla Panorama Av Principal Cal 3r, , Guayaquil, Guayas, Ecuador
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
HELD INSAN
The cosmetic 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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FILTH
The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/14/2012 | 05YYY01GRANOLA BARS | 473LABELING | Florida District Office (FLA-DO) |
| 9/14/2012 | 37JYY99SAUCES, N.E.C. | 473LABELING | Florida District Office (FLA-DO) |
| 9/14/2012 | 23GFT99MIXED NUTS, IN SHELL, N.E.C. | 473LABELING | Florida District Office (FLA-DO) |
| 9/14/2012 | 34GGT04CHOCOLATE COVERED CANDY PIECES, WITH NUTS AND FRUIT | 473LABELING | Florida District Office (FLA-DO) |
| 9/14/2012 | 33SYY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | 473LABELING | Florida District Office (FLA-DO) |
| 9/14/2012 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 313HELD INSAN | Florida District Office (FLA-DO) |
| 9/14/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 312FILTH | Florida District Office (FLA-DO) |
| 9/14/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 312FILTH | Florida District Office (FLA-DO) |
| 9/14/2012 | 34YGT99CHOCOLATE AND COCOA PRODUCTS, N.E.C. | 306INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 34KFT04CHOCOLATE BARS | 306INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 34FYY02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 306INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 186INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 186INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 186INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 186INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 186INSANITARY | Florida District Office (FLA-DO) |
| 9/14/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/14/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Cesar Gaona Jaramillo's FDA import refusal history?
Cesar Gaona Jaramillo (FEI: 3009709385) has 25 FDA import refusal record(s) in our database, spanning from 9/14/2012 to 9/14/2012.
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. Cesar Gaona Jaramillo's FEI number is 3009709385.
What types of violations has Cesar Gaona Jaramillo received?
Cesar Gaona Jaramillo has been cited for 6 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 Cesar Gaona Jaramillo come from?
All FDA import refusal data for Cesar Gaona Jaramillo 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.