ProRx confirms that it underwent a routine inspection, Sept. 9 – 19, 2025 by the U.S. Food and Drug Administration (FDA) of its registered 503B outsourcing facility.
Following the inspection, ProRx received a Form FDA 483 identifying certain observations. ProRx submitted a comprehensive written response to the FDA within the required timeframe and continues to engage with the agency as part of its standard review process.
Patient safety, product quality, and regulatory compliance remain foundational to ProRx’s operations. The company maintains established quality systems and adheres to current Good Manufacturing Practices (cGMP) as part of its ongoing commitment to continuous quality improvement. Read More >
