Warning Letter — Stavis Seafoods, LLC
The FDA issued a Warning Letter to Stavis Seafoods, LLC following an inspection by the Office of Inspections and Investigations that identified regulatory violations.
This affects Stavis Seafoods, LLC, as well as regulatory and quality assurance personnel responsible for seafood safety compliance and HACCP documentation.
The issuance of a Warning Letter signifies that previous responses to inspectional observations may have been insufficient to address underlying compliance gaps. This typically implies that the facility's food safety protocols or Hazard Analysis Critical Control Point (HACCP) plans require formal remediation to meet federal standards. failure to resolve these issues may lead to further enforcement actions, such as seizure or injunction.
Quality units should conduct a thorough review of existing HACCP plans and sanitation SOPs. Regulatory teams should ensure that all corrective actions documented in response to inspectional observations are fully implemented and verifiable prior to further FDA correspondence.
FDA Warning Letter issued to: Stavis Seafoods, LLC. 04/15/2026 — Office of Inspections and Investigations. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stavis-seafoods-llc-727785-04152026
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