# FDA 483 - Physio-Control, Inc. - November 26, 2019

Source: https://www.keypedia.com/records/483/physio-control-inc/3aa792f2-df40-4537-9319-fec6958bb707

> FDA 483 for Physio-Control, Inc. on November 26, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Physio-Control, Inc.
- Inspection Date: 2019-11-26
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Physio-Control, Inc. in Redmond, WA, was inspected by the FDA, resulting in four observations related to quality system deficiencies. The inspection revealed issues with adverse event reporting, corrective and preventive actions, design verification, and supplier evaluations. These findings indicate significant concerns with the firm's quality management system for medical device manufacturing.

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)
- [Investigator](https://www.keypedia.com/people/james-a-lane/f6cd3d8d-7de9-45c5-9380-7e0c5de4720e)

Company: https://www.keypedia.com/companies/physio-control-inc/cd3b1656-c525-4cfe-a3f2-d32143e20c7c

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