# FDA 483 - CAREstream Medical Ltd - February 06, 2026

Source: https://www.keypedia.com/records/483/carestream-medical-ltd/a05aab49-ce95-4ed4-a17b-787a62bde792

> FDA 483 for CAREstream Medical Ltd on February 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CAREstream Medical Ltd
- Inspection Date: 2026-02-06
- Product Type: device
- Office Name: Florida District Office
- Summary: CAREstream Medical Ltd, a medical device manufacturer in Lake Mary, FL, was cited for multiple deficiencies in its quality management system during an FDA inspection. The observations highlight inadequate documentation for QMS, design and development, and complaint handling, alongside failures in management review, software validation, UDI labeling, and supplier evaluation. These issues indicate significant non-compliance with regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2022-04-27](https://www.keypedia.com/records/483/carestream-medical-ltd/31820429-cc31-46c4-a6e1-b3a09744e9bf)

## Related Officers

- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9