483
Alevio, LLCFDA 483 - Alevio, LLC - November 10, 2021
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Alevio, LLC in Birmingham, AL, a tissue distributor, was inspected by the FDA on November 10, 2021. The inspection revealed two significant issues: a failure to record storage temperatures for human bone tissue products and a lack of established and documented procedures for facility cleaning and sanitation. These observations indicate deficiencies in environmental control and quality system documentation.
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