FDA 483 - Zhuhai United Laboratories Co. Ltd. - March 23, 2015

The FDA inspection of Zhuhai United Laboratories Co., Ltd. in Zhuhai, China, revealed significant deficiencies across multiple areas of its pharmaceutical manufacturing operations. Key issues include inadequate aseptic process simulations, ineffective environmental monitoring, and a lack of proper validation for critical equipment and sterilization processes. The firm also demonstrated poor quality assurance oversight and ineffective employee training, indicating a broad failure to adhere to GMP standards for sterile drug products and sterile API.