FDA Orders Donor Referral Services and Philip Guyett to Cease Manufacturing Human Cells, Tissues, and Cellular and Tissue-Based Products
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
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
