# FDA 483 - Klarity Medical Products LLC - May 20, 2026

Source: https://www.keypedia.com/records/483/klarity-medical-products-llc/f6dd2585-0f29-4135-a3ca-f0e0174d7de0

> FDA 483 for Klarity Medical Products LLC on May 20, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Klarity Medical Products LLC
- Inspection Date: 2026-05-20
- Product Type: device
- Office Name: FDA District Office — Cincinnati, Ohio
- Summary: An FDA inspection of Klarity Medical Products LLC in Heath, OH, revealed four significant observations regarding their quality management system. The firm failed to adequately validate manufacturing processes, monitor supplier performance, verify reworked products, and maintain records of design changes. These issues indicate a lack of robust control over critical aspects of medical device manufacturing and quality assurance.

## 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)
- [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/fda-district-office-cincinnati-ohio/b4972fd9-9db9-4cc6-9a4c-0146959c9d74