# FDA WARNING_LETTER - Conservas Ortiz S.A. - February 16, 2022

Source: https://www.keypedia.com/records/warning_letter/conservas-ortiz-sa/588b7150-e42e-449c-8a2f-bfab57c625f4

> FDA WARNING_LETTER for Conservas Ortiz S.A. on February 16, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Conservas Ortiz S.A.
- Inspection Date: 2022-02-16
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA issued a Warning Letter to Poligono Industrial La Estacion following an inspection from February 14-16, 2022, which revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's canned tuna products are deemed adulterated.

Key violations include:
1.  **Inadequate HACCP Plan - Critical Control Points (CCPs):** The HACCP plan for "CANNED TUNA PRODUCTS" failed to list CCPs for scombrotoxin (histamine) formation at the "(b)(4)" step after "(b)(4)," and for *Staphylococcus aureus* growth and toxin formation at multiple post-cooking steps until retorting.
2.  **Inadequate HACCP Plan - Critical Limits:** The plan lacked a critical limit for measuring internal fish temperatures when offloaded from harvest vessels at the "Fresh Fish and Frozen Fish reception CCP1 and CCP3" to control scombrotoxin.
3.  **Inadequate HACCP Plan - Inadequate Critical Limits:** Critical limits for scombrotoxin control at the "(b)(4)" CCP (sensory examination) and the "(b)(4)" CCP (combining refrigerated and unrefrigerated processing) were insufficient.
4.  **Inadequate HACCP Plan - Monitoring Procedures:** The monitoring frequency for undeclared allergens at the "(b)(4)"

## Related Officers

- [Director](https://www.keypedia.com/people/ann-m-oxenham/0013a6c1-4908-4506-9fb8-d0aa522e4ad4)

Company: https://www.keypedia.com/companies/conservas-ortiz-sa/2785291e-f9e2-4677-932f-5dd96535a444

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2