# FDA 483 - PatCen Healthcare Inc. - January 14, 2020

Source: https://www.keypedia.com/records/483/patcen-healthcare-inc/8f11b6d7-90aa-476d-a2b3-8329c8e846dd

> FDA 483 for PatCen Healthcare Inc. on January 14, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PatCen Healthcare Inc.
- Inspection Date: 2020-01-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: PatCen Healthcare Inc. in Bellevue, WA, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed deficiencies in the firm's medical device reporting procedures, specifically lacking timely transmission timelines. Additionally, the firm failed to ensure proper documentation of approval for quality system documents, as evidenced by missing signatures.

## Related Officers

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

Company: https://www.keypedia.com/companies/patcen-healthcare-inc/d76dede4-6da2-46b8-83f1-72558d1bc8e3

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