# FDA WARNING_LETTER - Pesquera Alvarez y Alvarez Ltda - May 10, 2013

Source: https://www.keypedia.com/records/warning_letter/pesquera-alvarez-y-alvarez-ltda/284d9e10-7be2-49c8-a7b1-53bbc1fd1337

> FDA WARNING_LETTER for Pesquera Alvarez y Alvarez Ltda on May 10, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Pesquera Alvarez y Alvarez Ltda
- Inspection Date: 2013-05-10
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: The FDA conducted an inspection of Pesquera Alvarez y Alvarez Ltd. in Chile on May 9-10, 2013, revealing serious violations of seafood HACCP (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110) regulations. The firm's frozen, vacuum-packed cooked king crabmeat products are deemed adulterated under Section 402(a)(4) of the FD&C Act due to insanitary conditions.

The firm's HACCP plan for frozen, vacuum-packaged cooked king crab meat is deficient. It fails to list critical control points for pathogen contamination and growth, specifically regarding cooling immediately after cooking (recommending cooling from 57.2°C to 21.1°C within 2 hours, then to 4.4°C within an additional 4 hours) and processing steps after cooling that involve significant handling time (recommending ambient temperatures at or below 4.4°C and monitoring every 2 hours). Additionally, the plan does not include a critical control point for the post-processing holding period, where the product is held before freezing, recommending refrigeration at 4.4°C or less with continuous temperature monitoring.

Furthermore, the HACCP plan does not list Clostridium botulinum germination, growth, and toxin formation as a reasonably likely food safety hazard for frozen, vacuum-packaged molded crabmeat. The FDA recommends

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- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/pesquera-alvarez-y-alvarez-ltda/ab7ac5c3-9718-43bb-aabf-2e7fc03c09d2

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