FDA 483 - HTO Nevada Inc - August 22, 2025

HTO Nevada Inc. dba Kirkman, a contract drug manufacturer in Lake Oswego, OR, received a Form 483 with eight observations, many of which were repeats. The inspection revealed significant deficiencies across quality control, production, stability testing, and labeling, including failures to investigate discrepancies, ensure contract lab GMP compliance, perform annual product reviews, and validate processes. These issues indicate a lack of adequate controls to ensure drug product identity, strength, purity, and quality.