FDA 483 - MSD International GmbH (Puerto Rico Branch) LLC - September 10, 2025

An FDA inspection of MSD International GmbH (Puerto Rico Branch) LLC in Las Piedras, PR, identified a critical quality system deficiency. The firm failed to adequately document investigations into out-of-specification (OOS) results for recalled finished drug products, specifically regarding batch record revisions and manufacturing process evaluations. This lapse in quality control led to product recalls and indicates a serious failure in their investigation procedures.