FDA 483 - Huaian Zongheng Bio-Tech Co., Ltd - July 05, 2019

An FDA inspection of Huaian Zongheng Bio-Tech Co., Ltd, a drug manufacturer in Huaian, China, from July 1-5, 2019, revealed significant deficiencies across multiple quality systems. The firm failed to ensure proper laboratory controls, stability testing, process validation, and equipment calibration. These issues indicate a lack of adequate controls to assure the identity, strength, quality, and purity of drug products.