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

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.