FDA 483 - PETNET Solutions, Inc. - February 19, 2016

An FDA inspection of Pet Net Solutions, Inc., a Positron Emission Tomography (PET) drug manufacturer in Fort Lauderdale, FL, revealed significant deficiencies in facility controls and aseptic processing. Observations included inadequate environmental monitoring during mold remediation, insufficient cleaning and sanitation procedures, and a lack of dynamic smoke studies. Furthermore, the firm's media fills failed to incorporate routine process interruptions, compromising the validation of aseptic technique.