# FDA 483 - Johnson Medtech LLC - November 27, 2023

Source: https://www.globalkeysolutions.net/records/483/johnson-medtech-llc/a1a30be7-8fb4-4b8a-8360-f9d2bfa09d70

> FDA 483 for Johnson Medtech LLC on November 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johnson Medtech LLC
- Inspection Date: 2023-11-27
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Johnson Medtech LLC, a medical device manufacturer in Vandalia, OH, received a Form FDA 483 with four repeat observations. The inspection revealed significant deficiencies in process validation, production process control, corrective and preventive action procedures, and product acceptance status. These issues indicate a systemic lack of adherence to quality system requirements, posing potential risks to device quality and patient safety.

## Related Documents

- [483 - 2019-06-06](https://www.globalkeysolutions.net/records/483/johnson-medtech-llc/f75dba56-2cd5-4fe6-9e7c-9ebd03323246)
- [483 - 2022-12-08](https://www.globalkeysolutions.net/records/483/johnson-medtech-llc/6531277b-9b92-4648-8009-a75c5100a87b)

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/johnson-medtech-llc/b92b143a-21be-4a5d-ad5d-cced4ff6abc0

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