# FDA 483 - Next Health, LLC - November 07, 2019

Source: https://www.globalkeysolutions.net/records/483/next-health-llc/8eae2bd9-8333-43b7-a201-1fafbf2e5c8e

> FDA 483 for Next Health, LLC on November 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Next Health, LLC
- Inspection Date: 2019-11-07
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Next Health, LLC in Norwalk, CT, an assembler of powered patient transfer systems, identified two significant observations. The firm was cited for inadequate procedures for design changes, specifically regarding documentation of patient weight tests and engineering change notices. Additionally, the firm failed to include a Unique Device Identifier (UDI) for its AgileLife Patient Transfer System in the device history record, as required for a Class 2 device.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-g-mayfield/ec045e12-d940-4f76-a17f-98ba4a8dd5b9)

Company: https://www.globalkeysolutions.net/companies/next-health-llc/a1cca61b-0058-4dd0-a6c6-fa44f97152b1

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