FDA 483 - Zhejiang Ludao Technology Co., Ltd. - August 14, 2017

Zhejiang Ludao Technology Co. Ltd. in Taizhou, China, a finished drug manufacturer, was cited for significant data integrity and quality control deficiencies during an FDA inspection. Observations included unreliable laboratory records, uncontrolled documents, inadequate stability testing methods, deletion of analytical data, and untrained personnel. The firm also failed to follow change control procedures for formulation changes and had poor warehouse maintenance and insufficient API identity testing.