483
Rogers Foam CorporationFDA 483 - Rogers Foam Corporation - February 25, 2026
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An FDA inspection of Rogers Foam Corporation in Mount Sterling, KY, from February 11-25, 2026, revealed two significant observations. The firm was cited for inadequate validation of production processes, specifically regarding an application process and a foam cutting process. Additionally, procedures for process validation lacked adequate inclusion of statistical techniques and rationale for sample sizes.
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