FDA 483 - RK Pharma Inc. - May 31, 2024

During an inspection conducted from May 20-31, 2024, at RK Pharma Inc. in Pearl River, NY, the FDA observed significant deviations from regulatory requirements, impacting the manufacturing of drug products such as Methylene Blue, Nicardipine Hydrochloride, and Cyclophosphamide injections. Key violations included the firm's failure to adequately complete Performance Qualification studies for critical manufacturing equipment, such as mixers, compounding vessels, and filling/capping machines. These studies did not sufficiently demonstrate suitability for intended operational parameters and commercial batch sizes.

Cleaning and maintenance practices were also found deficient. Disinfectant efficacy studies did not incorporate in-house microbial isolates, and cleaning validation protocols for shared equipment lacked precise sampling locations. Additionally, there was no documented maintenance program for critical ISO 5 machinery components. Other observations included inadequate visual inspection operator qualifications, which did not assess capabilities for tinted liquids or powder products across various vial sizes. The company also lacked procedures and documented evidence for electronic audit trail reviews of laboratory instrument software by the Quality Unit. Finally, during labeling machine performance qualification, the firm failed to record all rejected drug product containers, specifically excluding rejects that did not fit predefined categories. RK Pharma Inc. is required to address these observations to ensure compliance with good manufacturing practices and prevent adverse impacts on drug product quality, safety, and purity.