# FDA 483 - Monitored Therapeutics Inc - September 07, 2022

Source: https://www.globalkeysolutions.net/records/483/monitored-therapeutics-inc/744583e1-af36-4a1a-b2b9-2cf6a71223eb

> FDA 483 for Monitored Therapeutics Inc on September 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Monitored Therapeutics Inc
- Inspection Date: 2022-09-07
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Monitored Therapeutics Inc. in Dublin, OH, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately establish procedures for complaint handling, corrective and preventive actions, internal audits, and employee training. These issues indicate a lack of robust controls over critical quality processes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/monitored-therapeutics-inc/a6fded5c-f754-4498-84da-e5f378d02b16

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