# FDA 483 - CAREstream Medical Ltd - April 27, 2022

Source: https://www.keypedia.com/records/483/carestream-medical-ltd/31820429-cc31-46c4-a6e1-b3a09744e9bf

> FDA 483 for CAREstream Medical Ltd on April 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CAREstream Medical Ltd
- Inspection Date: 2022-04-27
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: CAREstream Medical Ltd, a medical device manufacturer in Lake Mary, FL, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, particularly concerning complaint handling, purchasing controls, design controls, design history file maintenance, and risk analysis for their platelet and plasma separator device. These issues indicate a lack of established and maintained procedures critical for ensuring device safety and effectiveness.

## Related Officers

- [Cody D. Rickman](https://www.keypedia.com/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)

Company: https://www.keypedia.com/companies/carestream-medical-ltd/807152c2-4197-4eb6-89eb-9d3d20538373

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