483
BLS Labs LLCBLS Labs LLC – FDA 483, Jun 17, 2026
Record Details
An FDA inspection of BLS Labs LLC, a tissue manufacturer in Mesa, AZ, revealed a significant deficiency in their complaint handling system. The firm's complaint files lacked sufficient information for proper review and evaluation, failing to determine if reported patient infections from tissue allografts represented a trend. The investigation into a consumer complaint regarding multiple patient infections was found to be inadequate in scope and failed to document identified trends.
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ID · 69c32698-1d1e-4c8b-a640-970aa9dcd4b4
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