FDA 483 - RK Pharma Inc. - August 12, 2022

RK Pharma Inc. in Pearl River, NY, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a lack of quality control unit authority over production records and investigations, inadequately qualified manufacturing and testing equipment, and insufficient cleaning and maintenance procedures. Additionally, the firm failed to follow written production and process control procedures, indicating systemic issues in their quality management system.