# FDA 483 - TZ Medical, Inc. - October 20, 2023

Source: https://www.keypedia.com/records/483/tz-medical-inc/c38c8f47-034f-44d6-9ed0-ecb83cc78453

> FDA 483 for TZ Medical, Inc. on October 20, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: TZ Medical, Inc.
- Inspection Date: 2023-10-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of TZ Medical, Inc. in Tualatin, OR, a manufacturer of medical devices, revealed a significant quality system deficiency. The firm's procedures for finished device acceptance were not adequately established, leading to the release of sterile defibrillation pads without ensuring complete sterility test results were received and reviewed. This indicates a failure in critical product release controls.

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.keypedia.com/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.keypedia.com/companies/tz-medical-inc/e0b2fc0e-0e36-4761-845c-863cb98d9d5a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822