483
Cryobank America LLCFDA 483 - Cryobank America LLC - January 13, 2025
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Record Details
Cryobank America LLC, a reproductive tissue establishment in Arlington, TX, was inspected by the FDA. The inspection revealed two observations primarily concerning inadequate record-keeping and issues with communicable disease testing documentation. Specifically, the firm failed to include required statements about CLIA certification for testing laboratories and lacked proper procedures for record retention.
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