FDA 483 - Artemis Bio-Solutions - December 01, 2021

Artemis Bio-Solutions, LLC, an own label distributor warehouse in Wood Dale, IL, received a Form 483 with 11 observations. The inspection revealed significant deficiencies in quality control unit oversight of contract manufacturing, lack of written procedures for critical operations like stability testing, complaint handling, warehousing, distribution, and returned products, as well as inadequate complaint investigations and employee training. These issues indicate a systemic failure to establish and follow basic cGMP requirements for drug product handling and quality management.