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

During an FDA inspection conducted from March 6-8, 2024, Rna Pharma, LLC, a contract manufacturer based in Blue Island, IL, received an FDA Form 483 detailing significant observations. The findings indicate potential non-compliance with current Good Manufacturing Practices (cGMP) for drug products.

Key issues identified include inadequate controls over their electronic Quality System, "Roma Cloud." The system's validation lacked crucial elements such as record retention, audit trail verification, and appropriate authorization, raising concerns about data integrity. The company also failed to implement proper change control for the transition from paper to electronic records and lacked procedures to ensure raw data originality and unmodifiability.

Furthermore, Rna Pharma, LLC had not established procedures to prevent objectionable microorganisms in non-sterile drug products, specifically failing to test finished products and component water for Burkholderia cepacia complex, despite releasing multiple product lots. Deficiencies were also noted in their quality control unit, with incomplete investigations and a lack of corrective and preventative actions for past product contamination incidents. Finally, facility design issues were observed, including inadequate space in the compounding area leading to drainage problems, and obstructed material flow due to product storage in aisles without proper evaluation. Rna Pharma, LLC is required to address these observations by developing and implementing comprehensive corrective and preventative actions to ensure full regulatory compliance.