Nelly del Carmen Alvarez Cedeno
⚠️ Moderate Risk
FEI: 2000011342 • Guayaquil, Guayas • ECUADOR
FEI Number
2000011342
Location
Guayaquil, Guayas
Country
ECUADORAddress
Cdla.Alborada Cuarta Etapa Mz F-B S.2, , 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
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.
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.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
LACKS FIRM
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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2012 | 28KGT99SPICES AND SEASONING, GROUND, CRACKED, WITH SALT, N.E.C. | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 3/16/2012 | 28KGT99SPICES AND SEASONING, GROUND, CRACKED, WITH SALT, N.E.C. | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 12/8/2011 | 28KGT99SPICES AND SEASONING, GROUND, CRACKED, WITH SALT, N.E.C. | New York District Office (NYK-DO) | |
| 11/17/2011 | 29CGT04MIXED DRINKS (NONALCOHOLIC BEVERAGES) | New York District Office (NYK-DO) | |
| 7/27/2010 | 29BGT99CARBONATED SOFT DRINK, N.E.C. | 218LIST INGRE | New York District Office (NYK-DO) |
| 11/16/2006 | 60LBJ99ANALGESIC, N.E.C. | New York District Office (NYK-DO) | |
| 11/16/2006 | 60LBJ99ANALGESIC, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nelly del Carmen Alvarez Cedeno's FDA import refusal history?
Nelly del Carmen Alvarez Cedeno (FEI: 2000011342) has 7 FDA import refusal record(s) in our database, spanning from 11/16/2006 to 9/24/2012.
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. Nelly del Carmen Alvarez Cedeno's FEI number is 2000011342.
What types of violations has Nelly del Carmen Alvarez Cedeno received?
Nelly del Carmen Alvarez Cedeno 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 Nelly del Carmen Alvarez Cedeno come from?
All FDA import refusal data for Nelly del Carmen Alvarez Cedeno 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.