FDA 483 - Little Moon Essentials LLC - January 18, 2024

Little Moon Essentials LLC, a drug manufacturer in Dania Beach, FL, was cited for significant deficiencies across its laboratory, production, and quality control systems. The firm failed to perform essential product and raw material testing, lacked written procedures for critical manufacturing processes and quality oversight, and did not have an adequate stability testing program or employee training. These issues indicate a severe lack of adherence to good manufacturing practices, potentially compromising drug product quality and safety.