Dulces Regionales Tres Reyes S.A. de C.V.
⚠️ High Risk
FEI: 1000323240 • Zamora, Michoacan • MEXICO
FEI Number
1000323240
Location
Zamora, Michoacan
Country
MEXICOAddress
Av Juarez 39, Poniente Colonia Centro, Zamora, Michoacan, 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
NEEDS ACID
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.
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)).
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.
UNDER PRC
The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
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).
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
AF-NONRSP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this acidified food pursuant to 21 CFR 108.25 (c)(2) appears to be inadequate to protect the public health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/28/2024 | 35BEE99RENNET, N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/1/2019 | 09CEY26MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED | Division of Southwest Imports (DSWI) | |
| 10/1/2019 | 09CEY26MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED | Division of Southwest Imports (DSWI) | |
| 1/8/2019 | 09CEF26MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED | Division of Southwest Imports (DSWI) | |
| 9/10/2018 | 09CEE26MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED | 181UNDER PRC | Division of Southwest Imports (DSWI) |
| 2/9/2015 | 09CEY26MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED | 3841AF-NONRSP | Southwest Import District Office (SWI-DO) |
| 1/12/2015 | 09CEP99MILK AND CREAM, N.E.C. | 181UNDER PRC | Southwest Import District Office (SWI-DO) |
| 11/25/2014 | 09CEY26MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED | 48NEEDS ACID | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Dulces Regionales Tres Reyes S.A. de C.V.'s FDA import refusal history?
Dulces Regionales Tres Reyes S.A. de C.V. (FEI: 1000323240) has 8 FDA import refusal record(s) in our database, spanning from 11/25/2014 to 6/28/2024.
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. Dulces Regionales Tres Reyes S.A. de C.V.'s FEI number is 1000323240.
What types of violations has Dulces Regionales Tres Reyes S.A. de C.V. received?
Dulces Regionales Tres Reyes S.A. de C.V. has been cited for 9 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 Dulces Regionales Tres Reyes S.A. de C.V. come from?
All FDA import refusal data for Dulces Regionales Tres Reyes 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.