# FDA 483 - K2 Health Products LLC - November 15, 2022

Source: https://www.globalkeysolutions.net/records/483/k2-health-products-llc/8aadafab-bec7-4ed1-84b2-9a28b4d420a4

> FDA 483 for K2 Health Products LLC on November 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: K2 Health Products LLC
- Inspection Date: 2022-11-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: K2 Health Products LLC, a medical device initial importer in Brooklyn, NY, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, specifically the lack of written procedures for Medical Device Reporting, complaint handling, and corrective and preventive actions. These observations indicate a fundamental failure to establish essential regulatory processes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/k2-health-products-llc/93d24e17-0d0c-45eb-b283-063cee465990

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