FDA 483 - Lianyungang Kangle Pharmaceutical Co., Ltd.

Lianyungang Kangle Pharmaceutical Co., Ltd, an API manufacturer, was cited for significant deficiencies during an FDA inspection. Observations include inadequate Quality Assurance review of raw data and data integrity for finished product testing, a complete lack of process validation for manufacturing steps, and insufficient assessment of cleaning validities during cleaning validations. Additionally, the firm failed to qualify packaging equipment, indicating systemic issues in quality control and manufacturing processes.