Merck Sharp & Dohme LLC – FDA EIR, Apr 16, 2021

An FDA Level 1 Good Manufacturing Practice (GMP) inspection of Merck Sharp & Dohme Corp.'s Durham, NC facility was conducted from April 7 to April 16, 2021. The inspection, guided by Compliance Program 7345.848, focused on the manufacturing of licensed biological drug products, including vaccines like M-M-R II and VARIVAX. The inspection covered quality, production, facilities and equipment, and laboratory systems. During this inspection, a FORM FDA-483 was issued, documenting several objectionable conditions. These included a failure to adequately manage and store drug product closures to prevent contamination; insufficient maintenance of manufacturing buildings; a quality control unit lacking full authority to investigate errors; incomplete batch production and control records; inadequate routine equipment performance checks; and the absence of written procedures to ensure drug product identity, strength, quality, and purity. Importantly, the inspection also verified that all objectionable conditions noted in the previous 2018 inspection had been corrected. In response to the current findings, company management committed to submitting a written response to the U.S. FDA, outlining their proposed corrective actions to address the identified issues.