Tissue Transplant Technology, Ltd. – FDA 483, Feb 18, 2022

Tissue Transplant Technology, Ltd. d/b/a Bone Bank Allografts in San Antonio, TX, an HCT/P manufacturer, was cited for significant deficiencies in its manufacturing processes for human amniotic fluid products. Observations included a lack of validated production controls, inadequate investigation of an adverse event complaint, and failure to establish expiration dates with appropriate stability data. Additionally, the firm failed to ensure components were tested and released by quality control before use.