FDA 483 - Merck, Inc. - June 18, 1997

An FDA inspection of Schering Plough Corp. in Kenilworth, NJ, revealed significant deficiencies in their pharmaceutical manufacturing operations. Observations included inadequate qualification of a process control computer, a lack of investigation into product color changes, and insufficient investigations into microbial contamination in the water system. These issues indicate a failure to maintain adequate quality control and validation practices.