Drugmaker Cited for GMP, Quality Issues

A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January 2014 site visit.

An IBA Molecular North America facility in Oakwood Village, Ohio, a radiopharmaceuticals maker that also does business as Zevacor Pharma, was not adhering to its own quality plans and procedures, according to the FDA.

The company did not have a record of investigations or findings following a complaint of radioactivity detected on the exterior of a dose syringe, according to the agency, and the company did not follow written procedures for handling complaints about product quality.