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.
規制動向2026年8月24日•1分で読めます
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.
PharmaCountryチームがまとめました · 出典： FDA.gov
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