483
RUA Medical (Prestwick)RUA Medical (Prestwick) – FDA 483, Oct 18, 2018
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.
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ID · 082c69f8-3bad-466c-9b55-b9ed2a3f5b2a
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