483
Biomerics Precision Concepts GroupBiomerics Precision Concepts Group – FDA 483, May 21, 2026
Record Details
An FDA inspection of Biomerics Precision Concepts Group in Winston Salem, NC, revealed two significant observations. The firm failed to adequately document risk management processes for product realization, specifically regarding controlled storage requirements and temperature data logging. Additionally, procedures for timely complaint handling were found to be inadequately documented, with several complaint records lacking required information.
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ID · 2edb7a5c-e04f-40d9-8853-a5bb3c6ce1c6
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