Johnson & Johnson Consumer, Inc – FDA 483, Mar 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.