483
Synchrony Labs, LLCFDA 483 - Synchrony Labs, LLC - January 17, 2025
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Record Details
An FDA inspection of Synchrony Labs, LLC, a non-clinical laboratory in Durham, NC, revealed two significant observations. The firm's quality assurance unit failed to properly document and assess deviations from approved protocols, and the study director did not ensure all study-related documentation was transferred to archives. These issues indicate deficiencies in quality system oversight and record management.
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ID · 811b7d74-24c6-44b0-9983-e27a001bddba