# FDA 483 - Tytek Medical Inc - June 21, 2023

Source: https://www.globalkeysolutions.net/records/483/tytek-medical-inc/9c764982-a00e-402c-87a6-17c16539edad

> FDA 483 for Tytek Medical Inc on June 21, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tytek Medical Inc
- Inspection Date: 2023-06-21
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Tytek Medical Inc. in Blue Ash, OH, was inspected by the FDA, resulting in two observations. The inspection revealed failures to report a device correction or removal to the FDA and a delay in submitting a Medical Device Report (MDR) for a serious injury event. These issues indicate non-compliance with medical device reporting regulations.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/tytek-medical-inc/422cbd57-4e14-4769-a409-abbc74b50520

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