Cord blood, cell loss and detached labelling

The TC informed: after inspection of product and labels, we detected some issues that we would like to inform or require further clarification: 1rst) The unit was received with labels detached from the bags (i.e. small compartment label was completely detached and big compartment label was no fixed). 2nd) The unit was selected for an expansion procedure that requires sectioning the small and the big compartments. Unfortunately, sealing in the bottom part was considered to be at risk of leakage if sectioned for detaching big and small containers. 3rd) Product colour apperance was reddish in one side and yellowish in the other side, suggesting a prolonged time from DMSO addition to actually freezing. 4th) We were surprised that a Pall Medical container was filled with 30.25 ml when the maximum recommended volume for this bag is 25 ml. We observed an irregular surface of the bag suggesting lack of an appropriate canister to homogenize the product between small and big compartments. 5th) Cord blood bank reported a cell loss during volume reduction up to 43%. Moreover, they provide data on viability of 87% and CFU counts of 30x105. In the Risk assessment form the CB bank refers that previous CT performed on a segment showed low viability. We are worried on potential potency issues. Gamida cell informed us follow: - Leakage was observed - A low number of cells post-thaw were obtained: 74x10e5 - The size of the pellet after the first centrifugation was smaller than usual - The blood had an orange colour - % viability upon thawing was 94% (usually the % viability is 97-98%). Consequently the unit was not infused.