# FDA 483 - Klarity Medical Products LLC - February 25, 2020

Source: https://www.keypedia.com/records/483/klarity-medical-products-llc/dfe61ff1-eea4-40e0-b388-2ae5641fa14d

> FDA 483 for Klarity Medical Products LLC on February 25, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Klarity Medical Products LLC
- Inspection Date: 2020-02-25
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Klarity Medical Products LLC in Newark, OH, was inspected and cited for multiple deficiencies in its quality system. The inspection revealed significant issues across corrective and preventive actions, design change control, supplier agreements, rework procedures, acceptance activities, complaint handling, and process controls for manufacturing medical devices like Vacuum Bags and BiteLok devices. These issues indicate a systemic failure to establish and follow adequate procedures for ensuring product quality and regulatory compliance.

## Related Documents

- [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)
- [483 - 2023-02-16](https://www.keypedia.com/records/483/klarity-medical-products-llc/402b67bf-ff73-43d7-9a3d-704b19a04a6f)

## 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