Productos Sane De Chapala, S.A. De C.V.
⚠️ Moderate Risk
FEI: 8194 • Chapala, Jalisco • MEXICO
FEI Number
8194
Location
Chapala, Jalisco
Country
MEXICOAddress
Calle Zaragoza No. 389, Col. CHAPALA CENTRO, Chapala, Jalisco, Mexico
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 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)).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2011 | 27YGE06PEPPER SAUCE (HOT, MILD, ETC.) | 83NO PROCESS | Southwest Import District Office (SWI-DO) |
| 5/25/2010 | 30PCT01COCKTAIL BASE, COMBINED TRUE FRUIT AND IMITATION FRUIT FLAVORS, LIQUID | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/25/2010 | 28LCT99MIXED SPICES AND SEASONINGS, LIQUID, WITH SALT, N.E.C. | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/25/2010 | 28LCT99MIXED SPICES AND SEASONINGS, LIQUID, WITH SALT, N.E.C. | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/25/2010 | 28LCT99MIXED SPICES AND SEASONINGS, LIQUID, WITH SALT, N.E.C. | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Productos Sane De Chapala, S.A. De C.V.'s FDA import refusal history?
Productos Sane De Chapala, S.A. De C.V. (FEI: 8194) has 5 FDA import refusal record(s) in our database, spanning from 5/25/2010 to 6/22/2011.
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. Productos Sane De Chapala, S.A. De C.V.'s FEI number is 8194.
What types of violations has Productos Sane De Chapala, S.A. De C.V. received?
Productos Sane De Chapala, S.A. De C.V. has been cited for 2 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 Productos Sane De Chapala, S.A. De C.V. come from?
All FDA import refusal data for Productos Sane De Chapala, S.A. De C.V. 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.