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法规动态2026年8月24日•1 分钟阅读

FDA Recall: CGMP Deviations Due to Intermittent Temperature Excursions

作者:PharmaCountry 团队

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

The U.S. Food and Drug Administration has initiated a recall after identifying current Good Manufacturing Practice (CGMP) deviations. The specific issue involved intermittent exposure to temperature excursions during product storage, which may affect product quality and safety. Manufacturers are advised to assess affected batches and implement corrective actions to prevent future occurrences.

由 PharmaCountry 团队整理 · 来源: FDA.gov

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