FDA Issues Two PET Drugmakers 483s for Inadequate Production Controls
The FDA issued Form 483s to two positron emission tomography drug manufacturers, citing both for poor manufacturing controls.
East Hartford, Conn.-based Cardinal Health, and Honolulu, Hawaii-based Hamamatsu/Queen’s PET Imaging Center were cited for lack of production and process controls to ensure their PET drugs meet standards.
The FDA also zapped Cardinal for not monitoring environmental conditions and not being able to justify its sampling locations. During the May 1 to 8 inspection, investigators noted that the technique used to clean the hot cell increased the risk of contamination, as did civilian clothes exposed under an operator’s sterile gown.
The firm also failed to investigate or take corrective actions when a batch failed to meet specifications, the Form 483 says.
During a May 12 to 14 inspection, Hamamatsu/Queen failed to produce master production and control records documenting all steps in the PET drug production process. Operators also failed to follow procedures for storing and handling components and closures, and used pH test strips that weren’t suitable.
In September, Cardinal’s Colton, Calif., facility received a Form 483 for poor data integrity and quality issues.