FDAnews Device Daily Bulletin

FDA Hits Nytone on Design-Change Procedures

Aug. 25, 2017

A Utah manufacturer of bedwetting alarms failed to spell out requirements its suppliers must meet and to establish a design-change procedure, the FDA said in an inspection report.

The company, Nytone Medical Products, also had not documented the corrective actions it had taken in response to complaints, and had not verified the effectiveness of those actions, the FDA said.

The agency noted problems with supplier requirements and design-change procedures that it previously identified in 2009 and 2014.

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