FDA WARNING_LETTER - Jiangsu Hengrui Pharmaceuticals Co., Ltd. - January 16, 2024

The FDA issued a Warning Letter to Jiangsu Hengrui Pharmaceuticals Co., Ltd. following a January 2024 inspection, citing significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Quality Control Unit Failure:** The firm's quality control unit failed to ensure CGMP compliance and data reliability. Investigators found discarded original CGMP records and unrestricted access to blank production batch records by the production manager, who also printed new records to transcribe information, discarding old ones. The FDA deemed the firm's response inadequate, requiring a comprehensive assessment of QA authority, resources, oversight, and a detailed CAPA plan for documentation systems to ensure data integrity. 2. **Inadequate Facility Design for Aseptic Processing:** The facility lacked adequate physical separation between Grade A and Grade B areas, compromising sterility. Issues included an open-air transition area for sterile equipment and vials, lack of dynamic smoke studies, and an open transfer cart for vials with insufficient environmental monitoring. The firm's proposed remediations were deemed insufficient, requiring a comprehensive risk assessment of contamination hazards and a detailed remediation plan.

The FDA requires a comprehensive investigation into data inaccuracies, a risk assessment of potential effects on drug quality, and a management strategy with a detailed CAPA plan, including a commitment to annual audits by a qualified consultant for at least two years. The firm must respond within 15 working days, detailing corrective actions and prevention plans.