FDA 483 - Houchin Community Blood Bank - October 30, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 2f7bb5af-e9d9-47fd-ba5d-41f0ffd03b39