FDA 483 - Johnson & Johnson Consumer, Inc - March 27, 2015

McNeil Consumer Pharmaceutical Products in Lancaster, PA, was inspected and cited for significant deficiencies in its manufacturing process controls and quality control unit authority. Observations included a lack of scientific rationale for compression speed ranges and failure to investigate out-of-range batches for Imodium, alongside the destruction of rejected product batches prior to the completion of deviation investigations. These issues indicate a serious breakdown in ensuring product quality and proper handling of non-conforming materials.