FDA 483 - LS Promotions Inc. - May 02, 2024

LS Promotions Inc., a human drug repackager and relabeler in Ronkonkoma, NY, was cited for numerous significant cGMP violations during an FDA inspection. The firm demonstrated a severe lack of quality control oversight, inadequate written procedures for production, process controls, and equipment management, and failed to ensure proper storage, stability testing, and component identity verification for its drug products, including sunscreens, hand sanitizers, and lip balms. These deficiencies indicate a systemic failure to maintain drug product quality, identity, strength, and purity.