483
Serim Research CorporationSerim Research Corporation – FDA 483, Apr 7, 2022
Record Details
Serim Research Corporation in Elkhart, IN, a medical device manufacturer, was inspected by the FDA. The inspection revealed one significant observation concerning the firm's device history records. Specifically, manufacturing records for Serim PeriScreen Test Strips did not align with the device master record, as material usage was outside established validated ranges.
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ID · 806332cd-09a5-4e83-b42c-36e788c151f8
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