FDA 483 - Peyman Saadat MD, Inc. - February 20, 2024

An FDA inspection of Peyman Saadat MD, Inc., a Reproductive Fertility Center in West Hollywood, CA, identified two significant observations. The firm made Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) available for distribution before completing donor eligibility determinations. Additionally, the firm's HCT/P records lacked the required statement confirming communicable disease testing was performed by a CLIA-certified laboratory or one meeting equivalent CMS requirements.