COMPLIANCE PROGRAM GUIDANCE MANUAL Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002A

https://www.gmp-compliance.org/files/guidemgr/7341.002--Inspection-of-Human-Cells--Tissues--and-Cellular-and-Tissue-Based-Products-(HCT-Ps).pdf

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms/UCM238872.pdf