# FDA WARNING_LETTER - La Sonorense, Inc. - March 21, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/la-sonorense-inc/95f234f5-018f-4bb9-aa50-cdc14131d4b7

> FDA WARNING_LETTER for La Sonorense, Inc. on March 21, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: La Sonorense, Inc.
- Inspection Date: 2020-03-21
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West IV
- Summary: The FDA issued a Warning Letter to a ready-to-eat (RTE) corn and flour tortilla manufacturer in Phoenix, Arizona, following an inspection from March 16-21, 2020. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117), rendering the food adulterated.

Key violations include:
1.  **Lack of Hazard Analysis:** The firm failed to identify and evaluate known or foreseeable hazards, including undeclared allergens (wheat), bacterial pathogens (E. coli, Salmonella, Listeria monocytogenes in flour), environmental pathogens (Salmonella post-(b)(4) step), and mycotoxins in wheat and corn flour. A voluntary recall of bulk Pressed Wheat Flour Tortillas occurred due to undeclared wheat.
2.  **No Preventive Controls:** The firm did not identify and implement preventive controls for any products to minimize or prevent hazards, including process, food allergen, sanitation, supply-chain controls, and a recall plan.
3.  **Missing Food Safety Plan:** A written food safety plan, including hazard analysis, preventive controls, supply-chain program, recall plan, monitoring, corrective action, and verification procedures, was not prepared or implemented.
4.  **Pest Exclusion Failure:** Open dock doors, a non-functioning air curtain, and gaps allowed pests. Rodent excreta

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)

Company: https://www.globalkeysolutions.net/companies/la-sonorense-inc/8443719d-a806-489e-8f8a-aa7b3e1b5f7c

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iv/683a371a-36d2-4745-90d9-200f1efd4090