FDA 483 - Ash Stevens LLC - December 22, 2010

An FDA inspection of Ash Stevens, Inc. in Riverview, MI, conducted from December 20-22, 2010, identified two significant issues. The firm failed to store API product reserve samples in adequately protective packaging and lacked specific operational parameters and comparative documentation within its written equipment maintenance procedures. These observations highlight deficiencies in the company's quality control and equipment management practices.