FDA 483 - Henan Kangdi Medical Devices Co. Ltd - March 07, 2019

Henan Kangdi Medical Devices Co. Ltd, a finished drug product manufacturer in Zhoukou, China, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to perform analytical testing on finished drug products, lacked a meaningful stability program, and accepted components without independent testing. Additionally, issues included inadequate material traceability, uncalibrated equipment, unsecured electronic procedures, and deficient batch production records, indicating severe control issues over drug product quality.