FDA 483 - Pinnacle Transplant Technologies, LLC - August 29, 2022

Pinnacle Transplant Technologics, LLC in Phoenix, AZ, was cited for significant deficiencies in its aseptic processing and quality control systems during an FDA inspection. The firm failed to adequately validate its aseptic manufacturing processes for injectable amniotic products, thoroughly investigate numerous batch sterility failures, and maintain proper environmental monitoring and equipment. These issues led to the distribution of products with sterility failures and potential contamination risks.