# FDA 483 - Indiana Coast Medical LLC - April 02, 2025

Source: https://www.keypedia.com/records/483/indiana-coast-medical-llc/cb1b5933-0d00-4830-b717-5799310fc628

> FDA 483 for Indiana Coast Medical LLC on April 02, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indiana Coast Medical LLC
- Inspection Date: 2025-04-02
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Indiana Coast Medical LLC, an HCT/P distributor in Valparaiso, IN, was cited for significant deficiencies in its operations. The inspection revealed a lack of established procedures for HCT/P manufacturing, storage, and distribution, as well as failures in evaluating incoming products for contamination. Additionally, the firm's storage areas were not adequately controlled to prevent mix-ups or improper release of HCT/Ps.

## Related Officers

- [Gabryelle J. Solverud](https://www.keypedia.com/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)
- [David A. Moore](https://www.keypedia.com/people/david-a-moore/361e4fe8-caf0-4320-963a-3838616850e2)

Company: https://www.keypedia.com/companies/indiana-coast-medical-llc/104bd106-626e-4192-b736-91b8d2ba82fb

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0