FDA 483 - PAI Holdings, LLC, dba Pharmaceutical Associates, Inc - September 02, 2022

VistaPharm, Inc. in Largo, FL, a drug manufacturer, was inspected and cited for significant deficiencies across three observations. The inspection revealed inadequate production and process controls for Clobazam Oral Suspension, unsanitary conditions due to vermin infestation in manufacturing areas, and failures within the quality control unit regarding Annual Product Reviews, finished product labeling, and good documentation practices. These issues indicate a lack of adherence to cGMP regulations.