483
Vista Lifesciences, Inc.FDA 483 - Vista Lifesciences, Inc. - November 04, 2025
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An FDA inspection of Vista Lifesciences, Inc., a medical device manufacturer in Englewood, CO, identified one significant observation. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequately established. This included failures to document root cause investigations and to ensure effectiveness checks verified that corrective actions addressed the original root causes.
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ID · d8db1c5d-1948-42ae-ae78-b0685c31c95b