The FDA cited a Cardinal Health subsidiary for issues with equipment cleaning, conformity testing and other processes at its Fort Lauderdale, Fla., PET drug manufacturing facility.
Cardinal Health 414 failed to test all batches to ensure they conformed to specifications before release, the agency found during its Oct. 16-26, 2018, inspection. One PET drug, fludeoxyglucose F18, for example, was not fully tested to determine its radionuclidic purity.
The facility also failed to document the results of an investigation into an injection lot of fludeoxyglucose F18 that failed to meet pH specifications. The investigation didn’t consider the components used to process the bulk sterile product.