FDA 483 - HTO Nevada Inc - August 22, 2025

HTO Nevada Inc. dba Kirkman, a contract drug manufacturer in Lake Oswego, OR, received an FDA Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, stability testing, process validation, and labeling, including repeat observations related to inadequate investigations, quality unit procedures, and annual product reviews. These issues indicate a lack of robust controls to ensure drug product identity, strength, purity, and quality.