FDA 483 - Merck Sharp & Dohme LLC

Merck Sharp & Dohme Corp., a sterile drug substance manufacturer in Elkton, VA, received a Form 483 with four observations during an inspection from February 25 to March 4, 2020. The observations primarily concern ineffective corrective actions for foreign material, inadequate Quality Assurance oversight of batch data, failure to properly investigate and follow up on out-of-specification results for HPV positive controls, and deficiencies in laboratory controls for HPV vaccine testing. These issues indicate significant concerns with quality systems and control over manufacturing and testing processes.