FDA to Inspect All PET Drug Plants, Training Cadre of Investigators

The FDA is training a cadre of investigators to inspect positron emission tomography (PET) drug plants, and applicants with multiple sites can expect to see the FDA at all of their facilities. The agency will not be using a risk-based approach at first, as most of these sites have never been inspected, according to a draft question-and-answer guidance on PET drugs. After the agency gains more experience with these inspections, it may change its approach, the guidance states.
Washington Drug Letter