Cecilia Payan S.A Dulces del Valle S.A
⚠️ Moderate Risk
FEI: 3004307923 • Buga, Valle Del Cauca • COLOMBIA
FEI Number
3004307923
Location
Buga, Valle Del Cauca
Country
COLOMBIAAddress
Carrera 11 3 52, , Buga, Valle Del Cauca, Colombia
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
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.
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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)).
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2017 | 33LYN12MIXED/ASSORTED SOFT CANDY WITHOUT NUTS, FRUIT OR CHOCOLATE) | Division of Southeast Imports (DSEI) | |
| 5/17/2010 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | New York District Office (NYK-DO) |
| 10/18/2006 | 21WCE03FIG, TOPPING OR SYRUP | Florida District Office (FLA-DO) | |
| 4/8/2005 | 21SGT03FIG (SUBTROPICAL AND TROPICAL FRUIT) | Florida District Office (FLA-DO) | |
| 4/8/2005 | 33LYT01CARAMEL CANDY BAR, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 4/8/2005 | 33LYT01CARAMEL CANDY BAR, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 4/8/2005 | 33TGT02CARAMEL TOPPING (TOPPING WITHOUT FRUIT, NUTS OR CHOCOLATE) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Cecilia Payan S.A Dulces del Valle S.A's FDA import refusal history?
Cecilia Payan S.A Dulces del Valle S.A (FEI: 3004307923) has 7 FDA import refusal record(s) in our database, spanning from 4/8/2005 to 4/26/2017.
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. Cecilia Payan S.A Dulces del Valle S.A's FEI number is 3004307923.
What types of violations has Cecilia Payan S.A Dulces del Valle S.A received?
Cecilia Payan S.A Dulces del Valle S.A has been cited for 7 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 Cecilia Payan S.A Dulces del Valle S.A come from?
All FDA import refusal data for Cecilia Payan S.A Dulces del Valle 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.