Loading…
Zhejiang Tianyu Pharmaceutical Co., Ltd. was cited for significant current good manufacturing practice (CGMP) violations in the production of active pharmaceutical ingredients (APIs), resulting in adulterated drug products. During a February-March 2022 inspection, the FDA found that the company failed to conduct adequate investigations into batch failures, specifically identifying at least four lots that failed impurity specifications for one API but testing only eight of numerous lots manufactured under a non-optimized process. Most critically, the company continued releasing and distributing API lots for approximately three months without implementing mitigating controls, despite identifying that the impurity had a higher risk of forming and before validating an analytical method to detect it.