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規制動向2026年8月24日•1分で読めます

FDA Identifies GMP Violations Affecting Sterility Assurance

執筆:PharmaCountry チーム

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

The FDA inspection found a lack of assurance of sterility and identified GMP violations that could impact product quality and sterility. As a result, the affected product is being recalled.

PharmaCountryチームがまとめました · 出典: FDA.gov