# FDA 483 - Tenacore Holdings, Inc - March 11, 2021

Source: https://www.keypedia.com/records/483/tenacore-holdings-inc/1580b162-a145-4640-9c4f-d8ac8f3b0357

> FDA 483 for Tenacore Holdings, Inc on March 11, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tenacore Holdings, Inc
- Inspection Date: 2021-03-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Tenacore Holdings, Inc., a medical device manufacturer in Santa Ana, CA, revealed that the firm's procedures for Corrective and Preventive Action (CAPA) were not adequately established. Specifically, several CAPA records from 2019 remained open, lacking evidence of validation and verification for the effectiveness of corrective and preventive actions. This indicates a significant deficiency in the firm's quality system regarding CAPA implementation.

## Related Officers

- [Stacey Masters](https://www.keypedia.com/people/stacey-masters/9e8b8c1f-9e00-4afa-b176-1f164fa9816d)

Company: https://www.keypedia.com/companies/tenacore-holdings-inc/04e05a2e-09d6-44e9-ab1c-a30ab3758896

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6