Tissue Transplant Attorneys
FDA Orders Donor Referral Services and Philip Guyett to Cease Manufacturing
Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and
to Retain HCT/Ps
The U.S. Food and Drug Administration (FDA) today ordered Donor Referral
Services (DRS), a human tissue-recovery firm, of Raleigh, NC, and its
owner, Philip Guyett, to immediately cease all manufacturing operations,
and to retain human cells, tissues, and cellular and tissue-based products
(HCT/Ps) after an inspection found serious deficiencies in its manufacturing
practices, including those governing donor screening and record keeping.
The order to cease manufacturing and retain HCT/Ps requires DRS and Philip
Guyett to immediately suspend any and all manufacturing steps, including
but not limited to the recovery and shipment of HCT/Ps. FDA's inspection
identified serious violations of the regulations, including the failure
to establish and maintain procedures for manufacturing steps performed
by DRS. In addition to the above stated violations, FDA also found several
instances where records provided by DRS to another HCT/P establishment
were at variance with the official death certificates FDA had obtained
from the state where the death occurred.
"Patient safety is at the forefront of today's action," said
Margaret O'K Glavin, Associate Commissioner, Office of Regulatory Affairs.
"Allowing the firm to continue to manufacture would present a danger
to public health by increasing the risk of communicable disease transmission."
Firms that recover HCT/Ps obtain tissue from human donors and send the
tissue to establishments that process it for use in implantation or transplantation.
HCT/Ps are used in a variety of procedures that can save lives, repair
limbs, relieve pain or enhance a patient's quality of life.
This action to protect public health is being taken under the agency's
new tissue regulations which took effect on May 25, 2005. Among other
mandates, the regulations require firms to properly screen and test donors
and, when needed, they enable FDA to take swift action in the interest
of public health.
"While most tissues are obtained and manufactured using appropriate
protections, some operators are not following acceptable practices,"
said Jesse L. Goodman, MD, MPH, director of FDA's Center for Biologics
Evaluation and Research. "Today's action is a clear sign of FDA's
intent to put a stop to any practices which place patients at unneeded
risk."
The regulations require that establishments process HCT/Ps in a way that
does not cause contamination or cross-contamination and that prevents
the introduction, transmission, or spread of communicable disease through
the use of the HCT/P. To date, FDA has not received reports of adverse
reactions (e.g., transmission of communicable disease to recipients) in
any patients who may have received the tissues in question. All tissue
products initially recovered from human donors by DRS have been recalled.
The agency will continue to investigate DRS' activities, monitor the recalls
to account for all distributed tissue and work cooperatively with tissue
processors and appropriate federal, state and local authorities. FDA will
take further actions as needed.
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