FDA 483 - UCLA Health Systems, Blood & Platelet Center - May 29, 2019

An FDA inspection of UCLA Health Systems, Blood & Platelet Center in Los Angeles, CA, revealed significant failures to follow written standard operating procedures. The firm did not adhere to its SOPs for managing adverse donor events, including timely follow-up with donors and completing required attempts for severe reactions. Additionally, compliance reviews for occurrence management reports were not completed within the specified timeframe, indicating systemic issues with recordkeeping and quality management.