Pinnacle Transplant Technologies, LLCFebruary 28, 2020

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

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Record Details

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.

Company: Pinnacle Transplant Technologies, LLC
Inspection Date: February 28, 2020
Product Type: Other
Office: Division of Pharmaceutical Quality Operations IV
People: Garrad R. Poole
Matthew J. Gretkierewicz (issuing_officer)

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ID · 4e434c61-e9f4-422e-9be8-6128b97aa8fb