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EBR clears FDA inspection step for Santa Clara WiSE facility
9:49am on Monday 28th of September, 2026 AEST
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Medical Devices
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EBR clears FDA inspection step for Santa Clara WiSE facility
9:49am on Monday 28th of September, 2026 AEST
Key Points
FDA inspection completed at Santa Clara facility
Two Form 483 observations issued
EBR promised to correct both observations
Final inspection classification and PMA decision remain pending
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