# FDA WARNING_LETTER - Manabi Export Panama S.A. - April 25, 2024

Source: https://www.keypedia.com/records/warning_letter/manabi-export-panama-sa/e6355ea1-96cb-4f9a-b489-5170333082ca

> FDA WARNING_LETTER for Manabi Export Panama S.A. on April 25, 2024. Product: Other. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Manabi Export Panama S.A.
- Inspection Date: 2024-04-25
- Product Type: Other
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On August 14, 2024, the FDA issued a Warning Letter to Manabi Export Panama S.A. following an inspection of their seafood processing facility in Chepo, Panama, on April 24-25, 2024. The inspection revealed serious violations of the seafood HACCP regulation (21 CFR 123), rendering their ready-to-eat (RTE) cooked clam meat in reduced oxygen packaging (ROP) adulterated under 21 U.S.C. § 342(a)(4).

The firm failed to conduct a hazard analysis and implement a written HACCP plan for their RTE clam meat, specifically lacking controls for: natural toxins and environmental chemicals at receiving, pathogenic bacteria survival through cooking, *Clostridium botulinum* toxin formation at labeling, and pathogen growth/toxin formation during post-cooking steps. Additionally, the firm lacked written sanitation procedures and adequate sanitation control records for various critical areas, including food contact surfaces, cross-contamination, handwashing facilities, and pest control, violating 21 CFR 123.11(c).

The FDA acknowledged the firm's May 8, 2024, response, which included a HACCP course receipt, but deemed it inadequate. Manabi Export Panama S.A. must respond within fifteen working days, outlining specific corrective actions, including a copy of their Hazard Analysis and HACCP plan,

## Related Officers

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

Company: https://www.keypedia.com/companies/manabi-export-panama-sa/dd2c4419-059c-48f2-b9d9-ffec622a1d08

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