Steris PLC – FDA 483, Nov 6, 2023

Steris PLC, a human drug manufacturer in St. Louis, MO, was cited for significant deficiencies in its quality system related to Septihol Hand Sanitizer. Observations include the absence of a written stability testing program, failure to conduct timely annual product reviews, and a lack of adequate written procedures for production and process controls. These issues indicate a systemic breakdown in ensuring product quality, purity, and strength, particularly concerning contract manufacturing oversight and product distribution conditions.