Digestive Care Inc – FDA 483, Jun 27, 2023

Digestive Care Inc. in Bethlehem, PA, a human drug manufacturer, was cited for failing to store drug products under appropriate temperature and humidity conditions. The inspection revealed that several storage areas, including those for active pharmaceutical ingredients, capsules, and finished products, lacked scientific-driven temperature mapping studies and rationale for data logger placement. Additionally, the controlled temperature warehouse had not undergone seasonal temperature mapping.