Philips Medical Systems (Cleveland) IncNovember 26, 2019

FDA 483 - Philips Medical Systems (Cleveland) Inc - November 26, 2019

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Record Details

Philips Medical Systems (Cleveland) Inc, a medical device manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's complaint handling procedures, resulting in a substantial backlog of unresolved and aged complaints. This issue was noted as a repeat observation from a previous inspection.

Company: Philips Medical Systems (Cleveland) Inc
Inspection Date: November 26, 2019
Product Type: Device
Office: Cincinnati District Office
People: Benjamin J. Dastoli (Investigator )
Laureen M. Geniusz (Investigator )

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ID · 55e8811c-e7b7-42a5-ae18-08af6a7bf891