法规动态

FDA、EMA、TGA 及全球法规动态

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2026年8月24日•1 分钟阅读

FDA Identifies GMP Violations Affecting Sterility Assurance

An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.

2026年8月24日•1 分钟阅读

FDA Recall: CGMP Deviations Due to Intermittent Temperature Excursions

The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.