483
Saluda Medical PTY LTDSaluda Medical PTY LTD – FDA 483, Jun 6, 2019
Record Details
Saluda Medical PTY LTD, a medical device manufacturer in Artarmon, Australia, was inspected by the FDA from June 3-6, 2019. The inspection revealed significant deficiencies in quality system procedures, including issues with software validation, corrective and preventive actions, non-conforming product control, and device master record maintenance. These observations indicate a need for improved adherence to regulatory requirements for medical device manufacturing.
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ID · 5bdabd2c-d2f9-428c-b93d-e857a66458c8
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