483
SleepNet CorporationSleepNet Corporation – FDA 483, Apr 28, 2022
Record Details
SleepNet Corporation, a medical device manufacturer in Hampton, NH, was inspected by the FDA, resulting in one observation. The inspection revealed an issue with the device history record for the Veraseal 3 mask, which failed to document a specific molding operation. This indicates a potential deviation from manufacturing in accordance with the device master record.
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ID · 61ad7629-b3da-4d0f-b219-6ca4ec1ba4a2
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