FDA 483 - LifeNet Health Northwest, LLC - April 11, 2019

LifeNet Health Northwest, LLC, a human tissue processor in Renton, WA, was cited for significant deficiencies during an FDA inspection. Observations included the distribution of contaminated human cells, tissues, and cellular and tissue-based products (HCT/Ps), inadequate controls to prevent cross-contamination, and poor facility maintenance. Additionally, the firm failed to properly validate computer software prior to its implementation.