483
Alcon Laboratories Ireland, LtdAlcon Laboratories Ireland, Ltd – FDA 483, Jan 15, 2015
Record Details
An FDA inspection of Alcon Laboratories Ireland, Ltd in Cork, Ireland, a medical device manufacturer, revealed a significant issue with Medical Device Report (MDR) submissions. The firm failed to submit MDRs within the required 30-day timeframe for devices that caused or contributed to serious injuries, with delays noted up to 111 days.
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ID · 7f776c53-4877-4a11-b59f-7857a2d79d25
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