# FDA 483 - RNA Coporation - December 19, 2025

Source: https://www.globalkeysolutions.net/records/483/rna-coporation/957b3c6f-d071-4456-acbd-dca91c483106

> FDA 483 for RNA Coporation on December 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RNA Coporation
- Inspection Date: 2025-12-19
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: RNA Corporation, a contract manufacturer in Blue Island, IL, received a Form 483 citing significant deficiencies in its quality control unit, particularly concerning electronic record audit trails and analytical raw data review. The inspection revealed a failure to follow established SOPs, a lack of raw data reviews, and untrained personnel for critical data integrity tasks. These issues indicate a systemic breakdown in data management and quality assurance processes.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gabriel-bermudez-picart/3263ce6e-a27d-4d4b-953c-4477c17aa182)

Company: https://www.globalkeysolutions.net/companies/rna-coporation/651ee15b-45bd-4f0b-9578-bc995a54dbaf

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669