FDA 483 - Bakkavor Foods USA Inc. - February 24, 2023

This FDA Form 483 was issued to Bakkavor Foods USA Inc., a ready-to-eat food manufacturer in Charlotte, NC, following an inspection from February 6-24, 2023. The inspection revealed significant deficiencies in sanitation preventive controls, including persistent Listeria monocytogenes contamination, inadequate implementation of process monitoring for temperature control, poorly maintained equipment, insufficient monitoring of sanitation practices, and a deficient seafood HACCP plan lacking critical control points. These observations indicate serious concerns regarding the firm's ability to prevent pathogen growth and ensure food safety.