FDA 483 - Lloyd Inc. of Iowa - November 06, 2025

Lloyd Inc. of Iowa, a drug product manufacturer in Shenandoah, IA, was cited for issues related to equipment design and maintenance during an FDA inspection. Specifically, a stability chamber used for drug stability products was found to be inadequately qualified and maintained. Products were stored in an unvalidated stacking configuration, and no subsequent qualification studies or temperature mapping had been performed since 1996 to ensure uniform conditions.