Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis)
⚠️ Moderate Risk
FEI: 3004304768 • San Salvador, San Salvador • EL SALVADOR
FEI Number
3004304768
Location
San Salvador, San Salvador
Country
EL SALVADORAddress
Cuba Avenue America St. 1730, Bo. San Jacinto, San Salvador, San Salvador, El Salvador
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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2015 | 03TFT23PANCAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 11/8/2010 | 03HGT07MIXED PLAIN COOKIES,BISCUITS AND WAFERS | Los Angeles District Office (LOS-DO) | |
| 11/8/2010 | 03HGT07MIXED PLAIN COOKIES,BISCUITS AND WAFERS | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 11/30/2009 | 07YGT99SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 11/28/2005 | 03MGB06FRUIT FILLED COOKIE,BISCUIT,WAFER DOUGH | 473LABELING | Division of Southeast Imports (DSEI) |
| 11/28/2005 | 03MGB06FRUIT FILLED COOKIE,BISCUIT,WAFER DOUGH | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis)'s FDA import refusal history?
Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis) (FEI: 3004304768) has 6 FDA import refusal record(s) in our database, spanning from 11/28/2005 to 4/20/2015.
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. Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis)'s FEI number is 3004304768.
What types of violations has Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis) received?
Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis) 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 Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis) come from?
All FDA import refusal data for Ernestina Castro, S.A de C.V. (Pan Santa Eduvigis) 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.