# FDA 483 - SeaStar Medical, Inc. - February 27, 2025

Source: https://www.globalkeysolutions.net/records/483/seastar-medical-inc/7f846bcb-3141-47e5-aa3b-72dcea9c95d6

> FDA 483 for SeaStar Medical, Inc. on February 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SeaStar Medical, Inc.
- Inspection Date: 2025-02-27
- Product Type: device
- Office Name: Denver District Office
- Summary: SeaStar Medical, Inc. in Denver, CO, a medical device manufacturer, was cited for a significant deficiency during an FDA inspection. The firm failed to perform the required process validation, specifically the Performance Qualification, for its Quelimmune Selective Cytopheretic Device for Pediatrics (SCD-PED) Clinical Kits. This indicates a lack of assurance that a critical manufacturing process consistently produces a product meeting its predetermined specifications.

## Related Officers

- [Celeta S. Coves](https://www.globalkeysolutions.net/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)
- [investigator](https://www.globalkeysolutions.net/people/marc-a-jackson/3bb8df6e-ab3a-4106-9a4b-aaaa307bc051)

Company: https://www.globalkeysolutions.net/companies/seastar-medical-inc/eb1bd230-596e-4593-94f7-356fa2ea4748

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