# FDA 483 - Johnson Medtech LLC - December 08, 2022

Source: https://www.globalkeysolutions.net/records/483/johnson-medtech-llc/6531277b-9b92-4648-8009-a75c5100a87b

> FDA 483 for Johnson Medtech LLC on December 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johnson Medtech LLC
- Inspection Date: 2022-12-08
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Johnson Medtech LLC, a medical device manufacturer in Vandalia, OH, was cited with six observations during an FDA inspection from November 17 to December 8, 2022. The inspection revealed significant deficiencies in process validation, corrective and preventive actions, product acceptance status, production process control, nonconforming material control, and device history records. Several observations were repeats from a previous inspection, indicating persistent issues with the firm's quality system.

## Related Documents

- [483 - 2019-06-06](https://www.globalkeysolutions.net/records/483/johnson-medtech-llc/f75dba56-2cd5-4fe6-9e7c-9ebd03323246)
- [483 - 2023-11-27](https://www.globalkeysolutions.net/records/483/johnson-medtech-llc/a1a30be7-8fb4-4b8a-8360-f9d2bfa09d70)

## 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