SALUDA MEDICAL PTY. LTD.August 25, 2022

FDA 483 - SALUDA MEDICAL PTY. LTD. - August 25, 2022

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Record Details

SALUDA MEDICAL PTY. LTD. in Macquarie Park, Australia, was inspected by the FDA from August 22-25, 2022. The inspection revealed that the firm's procedures for ensuring equipment is routinely calibrated were not adequately established or implemented. This resulted in equipment being used past its calibration due date.

Company: SALUDA MEDICAL PTY. LTD.
Inspection Date: August 25, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Christopher S. Genther (investigator)

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ID · f6f38ba5-89a9-4f6f-91e2-fc7c3b19255b