# FDA 483 - Spacelabs Healthcare, Inc. - September 15, 2022

Source: https://www.keypedia.com/records/483/spacelabs-healthcare-inc/c778636d-7a55-4487-b0ad-9440f3312dc3

> FDA 483 for Spacelabs Healthcare, Inc. on September 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spacelabs Healthcare, Inc.
- Inspection Date: 2022-09-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Spacelabs Healthcare, Inc. in Snoqualmie, WA, a medical device manufacturer, identified one observation. The firm's procedures for acceptance activities were found to be inadequately established, specifically concerning the switching rules for sampling plans for a controller board used in their 700/900 Ventilator. This indicates a lapse in quality system adherence regarding product acceptance.

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/spacelabs-healthcare-inc/b4938dc5-6f3f-4f5b-b42e-fef42d06c0e9

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