FDA历年检查483警告信汇总 中英.pdf

： FDA Warning Letters, Form 483 Observations and Establishment Inspection Reports – Preview FDA 警告文字，来自 483 观测资料和预先检查报告。 Important: Warning letters and other FDA inspection documentation should be interpreted in the context of full content. Just looking at extracts may be misleading. And sometimes they include good advice from the FDA not mentioned in the extracts. 重要性：警告文字和其他的 FDA 检查文件必须说明，根据上下文包括全部内容。仅是看摘 录可能被误解。并且有时要包括从 FDA 那里征求好的建议，而不是只提到摘录。 FDA 483 Ins