483
Avox Systems IncFDA 483 - Avox Systems Inc - August 16, 2021
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Record Details
Avox Systems Inc. in Lancaster, NY, a medical device manufacturer, was inspected by the FDA from 8/11/2021 to 8/16/2021. The inspection revealed significant deficiencies in quality system procedures, including unvalidated processes, inadequate finished device acceptance, missing design history files, and undocumented personnel training. These issues indicate a lack of robust controls over the manufacturing and design of their O2PAK Portable Oxygen Generators.
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ID · d23ac633-677e-4926-8989-9d5518e3cf1f