# FDA 483 - Troy Innovative Instruments Inc - July 26, 2024

Source: https://www.globalkeysolutions.net/records/483/troy-innovative-instruments-inc/7901f3e5-2fc2-4bda-859c-4c099557f67c

> FDA 483 for Troy Innovative Instruments Inc on July 26, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Troy Innovative Instruments Inc
- Inspection Date: 2024-07-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Troy Innovative Instruments Inc., a medical device contract manufacturer, was cited for significant quality system deficiencies including inadequate control of non-conforming products, insufficient documentation of corrective and preventive actions, and failures in maintaining complaint files. The inspection also revealed a lack of clear controls over suppliers and infrequent management reviews of the quality system.

## Related Documents

- [WARNING_LETTER - 2015-06-30](https://www.globalkeysolutions.net/records/warning_letter/troy-innovative-instruments-inc/7155f226-5fe2-4489-a6b5-030d710e4b90)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/troy-innovative-instruments-inc/8352e7d8-b82d-4a6b-863d-60283de159cb

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