Unomedical s.r.o.October 26, 2018

FDA 483 - Unomedical s.r.o. - October 26, 2018

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Record Details

An FDA inspection of Unomedical s.r.o., a manufacturer in Michalovce, Slovakia, revealed a significant issue regarding their quality system. The firm's procedures for quality audits were found to be inadequately established, specifically lacking detailed requirements for auditing records. This indicates a moderate severity finding related to quality system controls.

Company: Unomedical s.r.o.
Inspection Date: October 26, 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 · c1fb610a-6a5e-44f7-af07-8288601bdcac