FDA 483 - ICU Medical Inc - September 20, 2024

ICU Medical Inc. received a Form 483 citing ten observations primarily related to quality control, stability testing, and laboratory practices. Deficiencies included inadequate document control, unapproved logbooks, issues with stability study execution and environmental monitoring, and failures in microbiological contamination prevention. The firm also lacked thorough investigation procedures for out-of-specification results, had deficiencies in laboratory instrument qualification, and failed to comply with Drug Supply Chain Security Act verification requirements.