483 to PETNET Shows Failure to Qualify Staff

Siemens’ PETNET Solutions received an FDA Form 483 after failing to qualify its staff pharmacist to perform visual inspection for the appearance testing of certain injections. “Your staff pharmacist has not completed the visual inspection standard vial test to correctly identify particulates in injection solutions,” the form says. The pharmacist performed appearance testing on an unspecified number of batches of finished product without being qualified.
The GMP Letter