FDA 483 - CBR Systems Inc - January 17, 2024
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CBR Systems Inc, a cord blood bank in Tucson, AZ, was cited for multiple deficiencies during an FDA inspection. Observations included using unverified and potentially contaminated supplies, inadequate environmental controls leading to microbial contamination, failure to maintain proper shipping conditions for HCT/Ps, inaccurate labeling, and unapproved computer software validation. These issues indicate significant concerns regarding product quality, safety, and compliance with regulatory requirements.
ID · 558e5e66-c01d-4810-9dc3-c117c1f2a1a4