# FDA 483 - Vivorte, Inc. - November 23, 2021

Source: https://www.keypedia.com/records/483/vivorte-inc/3e33e438-7886-468a-a157-4aff7839de8e

> FDA 483 for Vivorte, Inc. on November 23, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivorte, Inc.
- Inspection Date: 2021-11-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Vivorte, Inc. in Louisville, KY, a manufacturer of medical devices, received a Form FDA-483 for several deficiencies related to its quality system. Observations included inadequate documentation of sterilization process monitoring and control, distribution of products prior to completion of required tests, and insufficient documentation of corrective and preventive actions. The firm also lacked adequate sampling procedures for sterile devices and failed to maintain records for product correction or removal actions.

## Related Officers

- [Talmane J. Fisher](https://www.keypedia.com/people/talmane-j-fisher/f69c101f-fbc7-4ca1-a6d1-1e25450c52b7)

Company: https://www.keypedia.com/companies/vivorte-inc/3c7f2fbe-cc5b-442c-8c9f-2c95f314fb08

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