# FDA 483 - Xtreem Pulse LLC - June 19, 2019

Source: https://www.globalkeysolutions.net/records/483/xtreem-pulse-llc/b513a33c-fdae-4cd5-be9c-c851cb2ad233

> FDA 483 for Xtreem Pulse LLC on June 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xtreem Pulse LLC
- Inspection Date: 2019-06-19
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Xtreem Pulse LLC, a medical device manufacturer in New York, revealed significant deficiencies in its quality system. The firm was cited for failing to establish written procedures for Medical Device Reporting (MDR), Corrective and Preventive Actions (CAPA), and the handling of consumer complaints. These observations indicate a fundamental lack of critical operational controls.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

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