FDA 483 - Lloyd Inc. of Iowa - September 15, 2023

Lion Inc., a manufacturer of human and animal drugs in Shenandoah, IA, was cited for seven observations during an FDA inspection from September 11-15, 2023. The inspection revealed significant deficiencies in facility maintenance, microbiological control, laboratory record-keeping, quality control unit procedures, environmental controls, complaint handling, and warehouse organization. These issues indicate a lack of adherence to good manufacturing practices, potentially impacting product quality and safety.