Your response failed to include information about what type of failure occurred, the root causes, the impact on other products manufactured under the same conditions, and all CAPA implemented regardless...
by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death....
Your failure to implement a stability programand generate data in support of your expiration dates limited your ability todetect and react to quality problems with your products.我们的调查人员发现你们对你们所有药品均未能实施稳定性检测计划...
While use of substandard (b)(4) that allow excessive (b)(4) again appears to have caused the specification failures, your response lacked sufficient relevant information on the root cause and scope of...
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