RUA Medical (Prestwick)October 18, 2018

FDA 483 - RUA Medical (Prestwick) - October 18, 2018

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Record Details

An FDA inspection of NUA Medical (Prestwick) in Prestwick, United Kingdom, identified a significant deficiency in their manufacturing operations. The firm failed to adequately establish procedures for controlling environmental conditions, specifically regarding the monitoring of non-viable airborne particle warning levels in their clean room.

Company: RUA Medical (Prestwick)
Inspection Date: October 18, 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 · 082c69f8-3bad-466c-9b55-b9ed2a3f5b2a