# FDA 483 - SleepNet Corporation - April 28, 2022

Source: https://www.globalkeysolutions.net/records/483/sleepnet-corporation/61ad7629-b3da-4d0f-b219-6ca4ec1ba4a2

> FDA 483 for SleepNet Corporation on April 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SleepNet Corporation
- Inspection Date: 2022-04-28
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/sleepnet-corporation/5f42fc45-3739-4e8a-9b90-650e4ef09181

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7