FDA EIR - Hanmi Pharma Co., Ltd - June 02, 2021

An FDA pre-license inspection of Hanmi Pharma Co., Ltd, located in Pyeongtaek, Korea, was conducted from May 25 to June 2, 2021. This inspection supported drug substance manufacturing, adhering to regulatory frameworks such as CP 7356.002M, CP 7346.832, and ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. The inspection resulted in the issuance of an FDA Form 483, detailing ten significant observations. Main issues included an inconsistent manufacturing process, inadequate shutdown and setup programs to ensure batch consistency, and failure to follow established process performance protocols. Deficiencies were also noted in Continued Process Verification Protocols, process understanding, and documentation for cleaning procedures. Additionally, a Quality Control release test standard operating procedure was found inaccurate, and both Corrective and Preventive Actions (CAPAs) and lifetime studies were deemed inadequate, alongside a lack of conformance to the submitted application. Hanmi Pharma management committed to submitting a written response to the FDA Form 483 within 15 working days. The initial field recommendation was to "Withhold," and the district decision was classified as "Official Action Indicated (OAI)," requiring a re-inspection.