Hillyard GMP – FDA 483, Oct 8, 2021

Hillyard GMP in Saint Joseph, MO, a manufacturer of medicated soap and hand sanitizer, was cited for significant deficiencies in its laboratory controls during an FDA inspection. The observations highlight a failure to establish scientifically sound specifications and test procedures, leading to concerns regarding raw material testing, manufacturing processes, data integrity, and water quality monitoring. These issues indicate a lack of robust quality assurance for their drug products.