Newborn Blood Banking Inc., a Florida-based company that stores umbilical cord blood for future use is accused of failing to comply with federal regulations for storing and distributing cord blood stem cells.

The plaintiff claims that Newborn fails to comply with U.S. Food and Drug Administration regulations for collecting, storing, processing, labeling, packaging and distributing cord blood stem cells.  Specifically, the plaintiff claims that Newborn routinely violates the FDA's regulations governing the collection, processing and storage of human cells, tissues and cellular/tissue based products (HCT/Ps).  The plaintiff claims that the FDA has identified deviations from requirements regarding donor eligibility screening and testing, processing controls, environmental control and monitoring, equipment and facilities, supplies and reagents, process validation, labeling controls and receipt of products.  The regulations have been in place since May 25, 2005, according to the plaintiff.  The plaintiff cites a February 19, 2010 order in which the FDA told Newborn to cease manufacturing of HCT/Ps.

The plaintiff seeks to represent a class of all people and entities that paid for cryopreservation collection and annual storage of cord blood at Newborn from May 25, 2005, to the present.