# FDA 483 - Cyber Medical Imaging Inc - October 31, 2022

Source: https://www.globalkeysolutions.net/records/483/cyber-medical-imaging-inc/71687724-2059-4a88-9805-159652d1c9cc

> FDA 483 for Cyber Medical Imaging Inc on October 31, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cyber Medical Imaging Inc
- Inspection Date: 2022-10-31
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cyber Medical Imaging Inc. in Los Angeles, CA, a Class II medical device manufacturer, was inspected by the FDA from October 20-31, 2022. The inspection revealed one significant observation concerning inadequate validation of software used in their quality system. Specifically, software for finished device testing, complaint handling, customer services, and inventory controls was released without proper verification reports.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/cyber-medical-imaging-inc/d9722aab-17b3-4a8e-af7c-378af9a88899

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6