# FDA 483 - Johnson Medtech LLC - June 06, 2019

Source: https://www.keypedia.com/records/483/johnson-medtech-llc/f75dba56-2cd5-4fe6-9e7c-9ebd03323246

> FDA 483 for Johnson Medtech LLC on June 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johnson Medtech LLC
- Inspection Date: 2019-06-06
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Johnson Medtech LLC, a medical device contract manufacturer in Vandalia, OH, received six observations during an FDA inspection. The firm was cited for inadequate procedures concerning process validation, corrective and preventive actions, and the control of nonconforming product. Additional deficiencies included failures to maintain product acceptance status, establish complaint handling procedures, and adequately document device history records.

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## Related Officers

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

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

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