483
Vivos Therapeutics, Inc.Vivos Therapeutics, Inc. – FDA 483, Aug 27, 2020
Record Details
Vivos Therapeutics, Inc. in Highlands Ranch, CO, a medical device manufacturer, was cited for significant deficiencies during an FDA inspection. The firm's design history file for its Vivos mRNA appliance® lacked required documentation and components, failing to demonstrate proper design control. Additionally, procedures for corrective and preventive actions (CAPA) were inadequately established and documented, leading to objectionable conditions in reviewed CAPA records.
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ID · 434f0091-2a1f-4abb-a0f8-2a77590f91f3
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