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FDA sent a warning letter to Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. after an inspection found the company failed to monitor and control quality.
FDA sent a warning letter to Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd., dated April 5, 2017, detailing what the agency called “significant deviations from current good manufacturing practice (CGMP) for API.” The letter follows a FDA inspection conducted from Sept. 26–29, 2016 of Teva’s 1889 Jingliu Road, Xiaoshan, Hangzhou, Zhejiang, China facility.
According to the warning letter, the company had failed to establish written procedures for monitoring the performance and control of processing steps. According to FDA, this failure may cause variability in API quality. Inspectors found that 10% of API batches manufactured from December 2014 to September 2016 failed to meet impurity limits and an additional 10% yielded out-of-trend (OOT) results. The company reprocessed rejected out-of-specification (OOS) batches but failed to implement effective corrective actions and preventive actions (CAPA) to fix flaws in the processes leading to the impurity results.
FDA asked the company to provide an updated investigation on the root cause of the OOS results and an improved CAPA plan. FDA requested explanations of root causes of batch failures and why some finished API batches yielded OOS results but passed testing. The agency also wants the company to explain process parameters and procedures for reprocessing lots.
The company was also cited for deficiencies in its validation sampling plans. In the warning letter FDA stated, “You did not conduct adequate monitoring and testing during process performance qualification stage to evaluate whether product quality was uniform throughout each batch. You only assessed water content at the drying step for homogeneity.” The agency is asking the company to explain how it plans to improve batch sampling and to provide quality system improvements.