FDA 483 - Enemeez, LLC dba Summit Pharmaceuticals - July 29, 2021

During an inspection, Eneemez, LLC dba Summit Pharmaceuticals, an OTC drug manufacturer, was cited for deficiencies in its stability program for mini enema drug products. Observations included a lack of specific, stability-indicating test methods and inadequate storage conditions for stability samples. The firm also failed to adhere to its written stability testing program, using improperly stored samples and switching contract laboratories without proper procedure.