SleepNet CorporationApril 28, 2022

FDA 483 - SleepNet Corporation - April 28, 2022

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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.

Company: SleepNet Corporation
Inspection Date: April 28, 2022
Product Type: Device
Office: Division of Northeast Imports
Person: John A. Sciacchitano (investigator)

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ID · 61ad7629-b3da-4d0f-b219-6ca4ec1ba4a2