FDA 483 - Merck Sharp & Dohme LLC

Merck, Sharpe & Dohme Corp. was cited for numerous deficiencies across its manufacturing and laboratory operations. Key issues include inadequate sterility testing procedures, insufficient environmental monitoring, and failures in quality control investigations for batch rejections and product defects. The inspection revealed systemic problems in ensuring product quality, purity, and potency, particularly concerning vaccine manufacturing and aseptic processing.