# FDA 483 - Covidien, LP - February 28, 2020

Source: https://www.keypedia.com/records/483/covidien-lp/23e1be91-5d87-4aa4-8a34-6310b81b1dd6

> FDA 483 for Covidien, LP on February 28, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covidien, LP
- Inspection Date: 2020-02-28
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/michael-g-mayfield/ec045e12-d940-4f76-a17f-98ba4a8dd5b9)

Company: https://www.keypedia.com/companies/covidien-lp/d641f53a-9d4b-4b04-aa52-a7e3fbed7428

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94