Date: February 23, 2010
The Food and Drug Administration (FDA) is issuing this notification to inform the health care community and the public that Newborn Blood Banking, Inc., a registered establishment that processes stems cells from umbilical cord blood, does not have adequate protections in place against the risks of communicable disease transmission. This notification is a result of an ongoing FDA investigation of Newborn Blood Banking’s Land O Lakes, Florida, establishment.
Newborn Blood Banking operates as a cord blood storage establishment, and has not distributed any of the cord blood stored at its facilities.
Cord blood, which contains hematopoietic progenitor cells, can be stored in the event that the cord blood is subsequently needed for treatment of the child from whom it is recovered. The cord blood may also be available for use by a close relative of that child. These products are regulated by FDA as human cells, tissues and cellular and tissue-based products (HCT/Ps), and are subject to FDA requirements regarding the recovery, processing, storage, labeling, packaging or distribution of the products, and the screening or testing of the donor (also known as donor eligibility).
As part of the agency’s risk-based inspectional approach, private cord blood banks were proactively identified as an inspection priority for fiscal year 2009. These newly regulated establishments were identified as part of FDA’s overall strategy to ensure the safety of HCT/Ps. FDA inspected 27 private cord blood banks around the country. An overwhelming majority of facilities inspected were in compliance with FDA regulations. The agency’s inspection of Newborn Blood Banking, however, identified serious violations of FDA regulations, and has resulted in FDA taking this significant enforcement action.
FDA’s ongoing investigation of Newborn Blood Banking has uncovered significant violations of the FDA’s HCT/P regulations. 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.
As a result of the violations of FDA regulations, on February 19, 2010, FDA issued an Order to Cease Manufacturing of HCT/Ps to Newborn Blood Banking, Inc. and to its Chief Executive Officer and Owner, Jon G. Suits. The Order relates to conduct occurring on or after May 25, 2005, the effective date of the applicable FDA regulations. The Order requires the firm to:
- immediately cease all manufacturing (including receipt of in-transit cord blood units) until compliance with FDA regulations has been achieved and FDA provides written authorization;
- not distribute any HCT/Ps recovered on or after May 25, 2005, which are in the firm’s possession or received after the date of the order; and
- continue to store all HCT/Ps recovered on or after May 25, 2005, which are in the firm’s possession or received after the date of the order, in compliance with the FDA requirements.
As of February 19, 2010, FDA is not aware of any cord blood units being distributed.
FDA’s HCT/P regulations are designed to prevent the introduction, transmission, or spread of communicable diseases. The umbilical cord blood processed and stored by Newborn Blood Banking is not subject to additional requirements for FDA premarket review or approval.
FDA staff are aware that these units are important to the donor families, and were collected, processed and stored at significant expense. If donor families wish to identify a facility that will store a cord blood unit affected by this order, we will work to facilitate the transfer of units to other storage facilities. Donor families who have identified an alternate storage facility should contact Newborn Blood Banking directly, and FDA (1-800-835-4709).
Getting More Information
For additional information regarding this notification, please contact FDA’s Center for Biologics Evaluation and Research at 1-800-835-4709 or by e-mail at firstname.lastname@example.org.
*This public health notification by the Center for Biologics Evaluation and Research is intended to quickly share safety information with health care providers and the public when the information available and our understanding of an issue are still evolving. We will revise this notice as new information merits and so encourage you to check this site for updates.