FDA Orders Donor Referral Services and Philip Guyett to Cease Manufacturing Human Cells, Tissues, and Cellular and Tissue-Based Products

August 31, 2006
BioPharm International Editors

FDA ordered Donor Referral Services (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.

FDA ordered Donor Referral Services (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 regulations require firms to properly screen and test donors. This action was taken under FDA’s new tissue regulations, which took effect on May 25, 2005 and which allow the agency to take swift action if needed to protect the public health. For more information, see: www.fda.gov/cber/compl/drs081806.htm

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