483
Covidien, LPCovidien, LP – FDA 483, Feb 28, 2020
Record Details
An FDA inspection of Covidien, LP in North Haven, CT, a medical device manufacturer, revealed one significant observation. The firm's procedures for receiving, reviewing, and evaluating complaints were found to be inadequately established. Specifically, complaints involving potential device failures, such as a defective Surgineedle spring, were not properly investigated.
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ID · 23e1be91-5d87-4aa4-8a34-6310b81b1dd6
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