# FDA 483 - Red Star Contract Manufacturing, Inc. - March 13, 2025

Source: https://www.keypedia.com/records/483/red-star-contract-manufacturing-inc/fb4900e0-d94d-4725-8522-7064878ed4cd

> FDA 483 for Red Star Contract Manufacturing, Inc. on March 13, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Red Star Contract Manufacturing, Inc.
- Inspection Date: 2025-03-13
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Red Star Contract Manufacturing, Inc. in Larwill, IN, an HCT/P distributor, revealed two significant observations. The firm failed to control storage areas to prevent mix-ups and contamination, specifically lacking a standard operating procedure for HCT/P product quarantine. Additionally, recorded storage temperatures were not periodically reviewed, and temperature monitoring probes were set outside the manufacturer's required range for HCT/P bone products.

## Related Officers

- [Gabryelle J. Solverud](https://www.keypedia.com/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)

Company: https://www.keypedia.com/companies/red-star-contract-manufacturing-inc/9c948d41-2a2e-40f9-ab53-a9aee2b71888

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