COMERZIALIZADORA PEPSICO S DE RL
⚠️ High Risk
FEI: 3024158008 • Saltillo • MEXICO
FEI Number
3024158008
Location
Saltillo
Country
MEXICOAddress
Blvd. Vito Alessio Robles 5600, , Saltillo, , Mexico
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
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)).
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).
INCONSPICU
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)).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/23/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/23/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/23/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/23/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/23/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/5/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/5/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/5/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/5/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/5/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/2/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) | |
| 6/2/2023 | 07BDT02CORN CHIPS, FRIED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is COMERZIALIZADORA PEPSICO S DE RL's FDA import refusal history?
COMERZIALIZADORA PEPSICO S DE RL (FEI: 3024158008) has 13 FDA import refusal record(s) in our database, spanning from 6/2/2023 to 6/23/2023.
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. COMERZIALIZADORA PEPSICO S DE RL's FEI number is 3024158008.
What types of violations has COMERZIALIZADORA PEPSICO S DE RL received?
COMERZIALIZADORA PEPSICO S DE RL 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 COMERZIALIZADORA PEPSICO S DE RL come from?
All FDA import refusal data for COMERZIALIZADORA PEPSICO S DE RL 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.