Hanlim Pharm Co., Ltd. – FDA Warning Letter, Apr 24, 2026

The FDA issued a warning letter to Hanlim Pharm Co., Ltd. following an inspection of its South Korean manufacturing facility from April 16 to April 24, 2026. This letter highlights serious violations of Current Good Manufacturing Practice (CGMP) standards, which are required under the Federal Food, Drug, and Cosmetic Act to ensure drug safety and quality. The inspection identified critical failures in the company"s sterile manufacturing processes. Key issues included poor aseptic techniques by staff, such as reaching over sterile containers, and inadequate airflow studies that failed to prove production lines were protected from contamination. Furthermore, the facility did not properly sterilize equipment that comes into contact with sterile drugs and lacked a robust environmental monitoring program to detect microbial risks. The company’s visual inspection process for identifying product defects was also deemed insufficient. The facility"s Quality Unit failed to exercise proper oversight, particularly concerning product stability testing and the maintenance of accurate, real-time records. Because these issues mirror violations cited in a previous 2019 warning letter, the FDA expressed concern regarding the effectiveness of executive management. In response, Hanlim Pharm has ceased production for the U.S. market. To resume operations, the company must engage an independent consultant to perform a comprehensive audit and develop a detailed remediation plan. This plan must address facility design, equipment sterilization, and quality oversight. The company is required to provide evidence of these corrections to the FDA before it can resume manufacturing drugs for the U.S. market.