# FDA 483 - Emerge Diagnostics, Inc. - April 26, 2019

Source: https://www.keypedia.com/records/483/emerge-diagnostics-inc/30167d10-cd4a-4714-9eca-aa1ad5f6ede5

> FDA 483 for Emerge Diagnostics, Inc. on April 26, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Emerge Diagnostics, Inc.
- Inspection Date: 2019-04-26
- Product Type: device
- Office Name: Denver District Office
- Summary: Emerge Diagnostics, Inc. in Carlsbad, CA, a Class II Medical Device Manufacturer, was cited for three observations during an FDA inspection. The firm failed to adequately establish design change procedures for software and firmware, lacked documentation for design outputs, and did not properly document corrective actions, specifically technician training, for complaint investigations.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)
- [Cso](https://www.keypedia.com/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)

Company: https://www.keypedia.com/companies/emerge-diagnostics-inc/5837e0b4-bdeb-4ba5-bda2-c5d5ce5e34e5

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face