by
Gus Iversen, Editor in Chief | April 30, 2025
FDA headquarters in Silver Spring, MD
SpectronRx, a radiopharmaceutical contract developer and manufacturer based in Indiana, announced it has successfully completed an FDA inspection of its Indianapolis facility, receiving a Section 704 letter with no observations.
The positive outcome follows a previous FDA inspection conducted on behalf of the European Medicines Agency at the company’s South Bend facility. SpectronRx stated that these developments align with its plans to expand operations to meet growing global demand for radiopharmaceuticals used in oncology and other critical disease areas.
“Global health leaders are increasingly concerned about the quality and availability of lifesaving radiopharmaceuticals,” said John Zehner, CEO of SpectronRx. “At SpectronRx, we are addressing these challenges by investing in world-class facilities, innovative equipment and highly skilled teams. Receiving no observations from the FDA underscores our commitment to industry-leading standards and our role in advancing radiopharmaceutical science.”
Ad Statistics
Times Displayed: 18661
Times Visited: 353 Stay up to date with the latest training to fix, troubleshoot, and maintain your critical care devices. GE HealthCare offers multiple training formats to empower teams and expand knowledge, saving you time and money
SpectronRx operates across radiopharmaceutical contract development (rCDMO), contract manufacturing (rCMO), isotope production and analytical testing. Its Indianapolis inspection result, the company noted, reinforces its focus on regulatory compliance and operational standards.
“This result reflects our commitment to regulatory compliance and maintaining the highest quality standards,” said Anwer Rizvi, president of SpectronRx. “We’re proud to reassure our partners that SpectronRx is a trusted choice for developing and manufacturing lifesaving diagnostics and therapies.”
SpectronRx employs over 200 people across five locations, serving 31 clients in 29 countries. Its facilities in Indiana, Danbury, Connecticut, and Europe encompass dozens of cleanrooms and 40 hot cells, covering nearly 200,000 square feet of production space. The company’s Nuclear Regulatory Commission (NRC) materials license authorizes the handling of over 25 isotopes for medical and research use.
SpectronRx’s continued investment in technology and infrastructure is intended to support the global supply chain for essential radiopharmaceuticals.
