Blood Center (The) Mandeville Donor Center – FDA 483, Mar 11, 2022

The FDA issued a Form 483 to The Blood Center Mandeville Donor Center following an inspection on March 11, 2022. The inspection revealed that personnel responsible for blood collection lacked adequate training and experience, specifically citing a donor technician's failure to adhere to standard operating procedures during a medical history and physical exam for a directed donor. This included misclassifying a directed donor, not presenting the consent form pre-donation, and failing to instruct the donor to review educational materials.