![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Drugmaker Cited for GMP, Quality Issues
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.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct