FDA 483 - JICE Pharmaceuticals Company - May 23, 2025

JICE Pharmaceuticals Company in Belding, MI, received a Form FDA 483 with four repeat observations during an inspection from May 21-23, 2025. The inspection revealed significant deficiencies in drug product testing, batch record management, component supplier qualification, and the stability program. These issues indicate a lack of adherence to good manufacturing practices, potentially impacting drug product quality.