FDA 483 - Houchin Community Blood Bank - October 30, 2024

Houchin Community Blood Bank received a Form FDA 483 for multiple deficiencies observed during an inspection from October 22-30, 2024. The observations include failures in donor eligibility screening for plateletpheresis, inadequate phlebotomy site preparation, non-adherence to standard operating procedures for donor identification, and deficiencies in obtaining informed consent from apheresis donors. These issues indicate a lack of control over critical blood collection processes.