483
Mako Surgical CorporationMako Surgical Corporation – FDA 483, Feb 23, 2018
Record Details
An FDA inspection of Mako Surgical Corporation in Davie, FL, revealed two significant issues. The firm failed to adequately document corrective and preventive action (CAPA) activities, specifically regarding the verification and validation of planned actions. Additionally, procedures for ensuring purchased products conform to requirements were not fully implemented, as evidenced by missing supplier documentation for a contract manufacturer.
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ID · 8c343385-a515-4af2-b5dc-5063a307b925
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