IBA Molecular 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.
There was also a lack of records documenting and ensuring proper equipment installation, the agency said.
“You do not follow written quality assurance procedures,” investigators wrote in the Form 483, detailing workers performing problematic tasks in aseptic areas, including handling trash while gloved and gowned.
Investigators also saw gaps in ceiling tiles in cleanrooms, potentially compromising environmental conditions in what was supposed to be a sterile room.