FDA 483 - Creative Foam Corporation - Bremen - November 24, 2025

An FDA inspection of Creative Foam Corporation - Bremen in Bremen, IN, revealed significant deficiencies across its quality system. The firm was cited for inadequate procedures related to corrective and preventive actions, process validation, complaint handling, and control of nonconforming products. Additionally, issues were noted with sampling plans, equipment calibration, and maintenance schedules, indicating a need for comprehensive quality system improvements.