483
LifeNet Health Northwest, LLCFDA 483 - LifeNet Health Northwest, LLC - April 11, 2019
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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.
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ID · 46a27a79-6c2c-4963-be71-4573659f38e7