FDA 483 - MSD International GmbH (Puerto Rico Branch) LLC - February 26, 2020

MSD International GmbH (Puerto Rico Branch) LLC in Las Piedras, PR, was inspected regarding its drug manufacturing operations. The inspection revealed significant deficiencies in the firm's investigation processes for unexplained discrepancies and batch failures, as these investigations did not adequately extend to other affected batches. Additionally, the firm failed to submit required Field Alert Reports to the FDA within the mandated three working days for multiple distributed drug batches that did not meet specifications.