# FDA 483 - RNA Pharma, LLC - March 08, 2024

Source: https://www.keypedia.com/records/483/rna-pharma-llc/42ccd33d-6026-4b59-9c2c-1e2e12b50d81

> FDA 483 for RNA Pharma, LLC on March 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RNA Pharma, LLC
- Inspection Date: 2024-03-08
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: RNA Pharma, LLC, a contract manufacturer in Blue Island, IL, was cited for significant deficiencies across its operations. Observations included inadequate controls over electronic systems and data integrity, a lack of procedures to prevent objectionable microbial contamination in non-sterile drug products, and failures in quality control investigations for out-of-specification products. Additionally, the facility's building design and space management were found to be unsuitable for proper operations.

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.keypedia.com/companies/rna-pharma-llc/aafc8946-f28f-4f0a-9343-17a1589e1e35

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