FDA 483 - Qualitest Pharmaceuticals - August 01, 2014

An FDA inspection of Qualitest Pharmaceuticals in Huntsville, AL, resulted in a Form 483 with two observations. The firm was cited for plumbing system defects that could lead to drug product contamination due to microbial growth in the water system. Additionally, the inspection revealed a failure to thoroughly review unexplained discrepancies and batch failures, including not rejecting batches with confirmed stability issues and an inadequate investigation into out-of-calibration equipment.