規制動向

FDA、EMA、TGA および世界の規制動向

#sterility ×

2026年8月30日•1分で読めます

FDA Recall Issued Due to Lack of Assurance of Sterility

The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.

2026年8月25日•1分で読めます

FDA Recall D-0296-2023 Issued Over Lack of Sterility Assurance

The FDA has initiated recall D-0296-2023 because the affected product failed to meet sterility assurance requirements.

2026年8月24日•1分で読めます

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23日•1分で読めます

Becton Dickinson UK recalls ChloraPrep 2% applicators over sterility concerns

Becton Dickinson UK Ltd is recalling batches of ChloraPrep 2% 1 mL and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential sterility breach in packaging.

2026年8月23日•1分で読めます

FDA Recalls Product Over Sterility Concerns Due to GMP Violations

The FDA has initiated a recall after an inspection revealed GMP violations that could compromise product sterility.

2026年8月23日•1分で読めます

FDA Recalls Product Due to Lack of Assurance of Sterility

The FDA has issued a recall for a product because sterility could not be assured.