483
Enemeez, LLC dba Summit PharmaceuticalsEnemeez, LLC dba Summit Pharmaceuticals – FDA 483, Jul 29, 2021
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.
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ID · 0344632e-4cc3-473d-bcd6-b7d7d62d6d3e
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