Medico Electrodes International LTD.August 23, 2018

FDA 483 - Medico Electrodes International LTD. - August 23, 2018

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Record Details

Medico Electrodes International LTD. in Noida, India, was inspected by the FDA from August 20-23, 2018. The inspection revealed a significant issue with the firm's complaint handling procedures. Specifically, the firm lacked adequate procedures for investigating device failures and failed to properly document complaint trend analyses.

Company: Medico Electrodes International LTD.
Inspection Date: August 23, 2018
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: John A. Sciacchitano (investigator)

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ID · b3d846a1-b32f-4a07-a7e6-150869c31969