FDA 483 - Little Moon Essentials LLC - July 10, 2025

Little Moon Essentials LLC, a drug manufacturer in Dania Beach, FL, was cited for significant deficiencies in its quality control and manufacturing processes. The inspection revealed a lack of validated manufacturing processes, inadequate stability testing, and insufficient control over equipment cleaning, labeling, and raw material testing. Additionally, the firm failed to maintain proper batch records, written SOPs for critical GMP topics, annual product reviews, and calibration records.