FDA 483 - Creative Foam Corporation - February 04, 2026

Creative Foam Corporation dba Mt. olive in Mooresville, IN, a repacker of drug products, was cited for a significant quality system deficiency. The firm failed to perform Annual Product Reviews for its drug products, including medicated (b)(4), since 2022, and lacked a procedure for conducting these reviews. This indicates a failure to adequately evaluate product quality standards and ensure ongoing compliance.