Purpose: An inspection has uncovered significant violations of the U.S. Food and Drug Administration’s (FDA) regulations at Pacific Coast Tissue Bank, a manufacturer of human bone tissue, and those violations provide reasonable grounds to believe that there is a danger to the health of tissue recipients.
Summary of Safety Issue
The FDA inspection of Pacific Coast Tissue Bank in Los Angeles, California, a registered establishment that manufactures and distributes human cells, tissues and cellular and tissue-based products (HCT/Ps), uncovered significant violations of FDA’s HCT/P regulations. An FDA inspection conducted between April 24 and June 19, 2012, identified significant violations of 21 CFR 1271. The agency has determined that the establishment does not provide adequate protections against the risks of communicable disease transmission due to these significant violations and that there are reasonable grounds to believe that the HCT/Ps pose a danger to health. As a result, on November 5, 2012, FDA issued an Order to Cease Manufacturing, Recall and Destroy of HCT/Ps to Pacific Coast Tissue Bank and its Medical Director, Eli Gendler, M.D., Ph.D. The Order requires:
- the immediate cessation of all manufacturing until compliance with the regulations in 21 CFR 1271 has been achieved and FDA provides written authorization to resume such operations;
- the destruction of all HCT/Ps that are in the establishment’s possession; and
- within five working days from the date of receipt of the Order, the recall and destruction of all HCT/Ps distributed since March 19, 2009, the date the establishment began manufacturing HCT/Ps.
Specifically, FDA’s inspection and record review noted significant noncompliance with the relevant federal regulations pertaining to HCT/Ps including, but not limited to, the following:
- Failure to evaluate each incoming HCT/P for the presence and significance of microorganisms.
- Failure to validate and approve manufacturing processes according to established procedures.
- Failure to process each HCT/P in a way that does not cause contamination or cross-contamination during processing, and that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P.
- Failure to adequately control and monitor environmental conditions and provide proper conditions for operations, where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment.
- Failure to clean, sanitize, and maintain equipment according to established schedules.
- Failure to maintain the processing facility in a good state of repair, adequate to prevent contamination of HCT/Ps.
Based on the inspectional findings, FDA believes the establishment has not taken adequate steps to provide protection against the risks of communicable disease transmission due to these serious violations.
Recommendations for Tissue Recipients
FDA recommends that recipients of tissues manufactured at this establishment discuss with their primary care provider any illnesses or adverse reactions experienced after receiving the tissue.
Recommendations for Health Professionals
- Review the Order to Cease Manufacturing, Recall and Destroy issued to the Pacific Coast Tissue Bank and its Medical Director, Dr. Eli Gendler for information on the nature of the establishment’s violations.
- Promptly comply with the recall notification from Pacific Coast Tissue Bank.
- Be alert for any adverse reactions occurring in tissue recipients.