# FDA 483 - Xtreem Pulse LLC - June 29, 2022

Source: https://www.globalkeysolutions.net/records/483/xtreem-pulse-llc/92d69a2d-bf6a-4d91-abd9-7ab8c39e3ea2

> FDA 483 for Xtreem Pulse LLC on June 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xtreem Pulse LLC
- Inspection Date: 2022-06-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Xtreem Pulse LLC, a specification developer in New York, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for design changes, purchasing controls, and overall design control for their PureLift Face and PureLift Pro facial stimulation devices. These issues indicate a lack of documented processes for critical aspects of medical device development and manufacturing.

## Related Documents

- [483 - 2019-06-19](https://www.globalkeysolutions.net/records/483/xtreem-pulse-llc/b513a33c-fdae-4cd5-be9c-c851cb2ad233)
- [483 - 2023-10-13](https://www.globalkeysolutions.net/records/483/xtreem-pulse-llc/9fb6a6c2-b3f3-452c-932f-ffb40b61e711)

## Related Officers

- [Colin E. Tack](https://www.globalkeysolutions.net/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.globalkeysolutions.net/companies/xtreem-pulse-llc/4369da2f-f49e-455a-97cd-8b3efa71f387

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961