Tissue Establishment Inspection & Compliance Related Documents

Compliance Program 7342.007 Addendum - Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)

FDA Forms Task Force on Human Tissue Safety - 8/30/2006

FDA Public Health Notification: Donor Referral Services - 8/30/2006

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 - 8/18/2006

Order to Cease Manufacturing and to Retain HCT/Ps - Biomedical Tissue Services, Ltd - 2/6/2006

Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006 (CDC) - 5/26/2006

Compliance Program 7341.002A - Inspection of Tissue Establishments
(covers human tissue recovered before 5/25/2005)

Compliance Program 7341.002 - Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
(covers human tissue recovered after 5/25/2005)

FDA HCT/P Inspection Data: 1994-2005