FDA 483 - Pinnacle Transplant Technologies, LLC - February 28, 2020

Pinnacle Transplant Technologies, LLC in Phoenix, AZ, a tissue processor, was cited for significant deficiencies during an FDA inspection. The firm failed to validate its aseptic and sterilization processes for its human allograft product, PalinGen Flow, and lacked established procedures for investigating microbial contamination and sterility failures. Additionally, the company did not thoroughly investigate failed batches or environmental microbial positives, indicating a severe lack of quality control in preventing contamination.