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Responses that lack root cause analysis CAPA without clear owners or timelines We will correct this, promises with no evidence Missing documentation to support completed actions Key lessons Always approach a 483 as if it were a regulatory submission

demonstrated the beneficial effect of protecting motor neurons from injury by stimulating the production of GSH, decreasing the volume of brain infarcts in SpragueDawley rat brain following middle artery carotid occlusion

Whole cell extracts containing GST-DHFR ( Panel A ) and GST alone ( Panel B ) were loaded, washed, and eluted from glutathione resin columns

The synaptosome P2 fraction was filtered using a 40-m pore cell strainer (BD Biosciences, Franklin Lakes, NJ) and incubated in a cell culture dish (30 mm) while agitating at room temperature for 1015 min during recovery 61