Yibin Lihao Bio-technical Co., Ltd. – FDA Warning Letter, Aug 6, 2019

The FDA issued a Warning Letter to Yibin Lihao Biotechnical Co., Ltd. following an inspection from July 31 to August 6, 2019, identifying significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to prepare and use production and control records:** The firm manufactured two batches of crude heparin (CU190726, CU190727) just before the inspection without corresponding manufacturing and testing records, despite initially denying production. Their response was inadequate regarding remediation of documentation practices and assessing the impact on distributed drugs. 2. **Failure to establish an effective quality management system:** The firm lacked adequate control over critical documentation, with records found disorganized. Contradictory statements were made regarding the authenticity of batch records, and complete records were only provided for two out of 30 batches of crude heparin. This calls into question the traceability of all manufactured drugs.

The FDA requires a complete reconciliation of all distributed drugs, a comprehensive assessment of documentation systems with a detailed CAPA plan, and a robust quality management system remediation plan. The firm's data integrity is compromised, and they are strongly advised to retain a qualified consultant.

As a result, the FDA placed the firm on Import Alert 66-40 and 55-03 on January 15, 202