483
Philips Healthcare - VSS - Shanghai CDCPhilips Healthcare - VSS - Shanghai CDC – FDA 483, Apr 11, 2019
Record Details
An FDA inspection of Philips Healthcare - VSS - Shanghai CDC, a medical device manufacturer in Shanghai, China, identified two observations related to inadequate procedures. The firm's procedures for design change did not adequately address root cause documentation for Post Release Change Requests. Additionally, their quality audit procedures lacked adequate detail regarding sample selection parameters.
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ID · 99dcfcb6-e620-4069-9bbb-70be10a984ee
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