FDA 483 - EMS Acquisition Corp - October 24, 2025

EMS Acquisition Corp, a human drug manufacturer in Hatfield, PA, was cited for significant deficiencies across its quality control and production processes. Observations included inadequate component testing, failure to test for objectionable microorganisms in OTC drug products, poor computer system controls impacting data integrity, and deficient process validation for critical manufacturing steps. These issues indicate a lack of robust controls to assure drug product identity, strength, purity, and quality.