Covidien, LPFebruary 28, 2020

FDA 483 - Covidien, LP - February 28, 2020

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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.

Company: Covidien, LP
Inspection Date: February 28, 2020
Product Type: Device
Office: Division of Northeast Imports
Person: Michael G. Mayfield (investigator)

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ID · 23e1be91-5d87-4aa4-8a34-6310b81b1dd6