Enemeez, LLC dba Summit PharmaceuticalsJuly 29, 2021

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

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Record Details

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.

Company: Enemeez, LLC dba Summit Pharmaceuticals
Inspection Date: July 29, 2021
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: James B. Arnett (Sales Store Checker)
Joel D. Hustedt

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ID · 0344632e-4cc3-473d-bcd6-b7d7d62d6d3e