# FDA 483 - Klarity Medical Products LLC - February 16, 2023

Source: https://www.keypedia.com/records/483/klarity-medical-products-llc/402b67bf-ff73-43d7-9a3d-704b19a04a6f

> FDA 483 for Klarity Medical Products LLC on February 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Klarity Medical Products LLC
- Inspection Date: 2023-02-16
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Klarity Medical Products LLC in Heath, OH, was inspected by the FDA, revealing significant issues in their manufacturing processes. The inspection found failures in process validation for critical welding, inadequate acceptance activity procedures, and a lack of maintained device master records for their medical devices. These observations indicate a need for comprehensive improvements in their quality system.

## Related Documents

- [483 - 2020-02-25](https://www.keypedia.com/records/483/klarity-medical-products-llc/dfe61ff1-eea4-40e0-b388-2ae5641fa14d)
- [WARNING_LETTER - 2020-02-25](https://www.keypedia.com/records/warning_letter/klarity-medical-products-llc/e47cf541-b6b9-4d11-9da6-daea5ecf5c27)
- [483 - 2021-07-09](https://www.keypedia.com/records/483/klarity-medical-products-llc/5488b996-5c84-471b-ab81-5e158ded7ac8)

## Related Officers

- [investigator](https://www.keypedia.com/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.keypedia.com/companies/klarity-medical-products-llc/f38ac6d6-833a-4f2f-850c-d48471d42060

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22