# FDA 483 - Intelligent Retinal Imaging Systems Inc. - December 06, 2018

Source: https://www.globalkeysolutions.net/records/483/intelligent-retinal-imaging-systems-inc/a93b3484-0b43-468f-b914-6971149e6f61

> FDA 483 for Intelligent Retinal Imaging Systems Inc. on December 06, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intelligent Retinal Imaging Systems Inc.
- Inspection Date: 2018-12-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Intelligent Retinal Imaging Systems Inc. in Pensacola, FL, a medical device manufacturer, was inspected and cited for significant deficiencies across its quality system. The inspection revealed inadequate software validation documentation, poorly established design validation procedures, incomplete risk analysis, and insufficient procedures for complaint handling and corrective and preventive actions. These issues indicate a systemic lack of robust quality management practices.

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/intelligent-retinal-imaging-systems-inc/fe1c6bbb-b3a2-47f4-b367-b684a2ef98d0

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6