483
Allergen MedicalAllergen Medical – FDA 483, Jul 7, 2015
Record Details
An FDA inspection of Allergan Medical in Medford, MA, a medical device manufacturer, revealed two significant observations regarding Medical Device Reporting (MDR) requirements. The firm failed to submit MDRs within the required 30-day timeframe for device malfunctions and also failed to submit several MDRs for events that may have caused or contributed to death or serious injury.
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ID · eea4f383-2643-4ebb-a0e1-4517c86e510f
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