FDA 483 - Merck Sharp & Dohme LLC - January 22, 2025

An FDA inspection of Merck Sharpe & Dohme LLC in Elkton, VA, revealed six observations primarily concerning contamination control and quality system deficiencies in sterile drug manufacturing. The findings include inadequate investigations into persistent mold contamination, a lack of detailed written procedures for aseptic processes, and unvalidated cleaning and inspection methods. These issues indicate significant concerns regarding the firm's ability to assure the quality and purity of its sterile drug products.