FDA flags more Olympus safety problems in import block and warning letter

T2Covered by 1 source · first reported by BioPharma Dive / Healthcare Dive / MedTech Dive at 22 Oct, 15:20 UTC

The FDA import alert broadens the scope of a 2025 import action covering dozens of endoscopes and comes two weeks after a new warning letter identified numerous quality system violations.

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Sources

• T2FDA flags more Olympus safety problems in import block and warning letterBioPharma Dive / Healthcare Dive / MedTech Dive22 Oct, 15:20