# FDA 483 - Covidien LP - November 18, 2022

Source: https://www.globalkeysolutions.net/records/483/covidien-lp/563e8d37-a3fd-4c84-8b36-59678d5a131f

> FDA 483 for Covidien LP on November 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Covidien LP
- Inspection Date: 2022-11-18
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Covidien LP in Mansfield, MA, a medical device manufacturer, revealed significant deficiencies in their complaint handling procedures. The firm failed to establish adequate timeframes for processing product complaints, resulting in substantial delays in opening and completing investigations. This led to a failure to timely report a reportable event to the FDA, indicating a serious lapse in their quality system.

## Related Documents

- [WARNING_LETTER - 2012-02-09](https://www.globalkeysolutions.net/records/warning_letter/covidien-lp/a0cc9f70-5c1e-4d4d-a82f-7af430940235)

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.globalkeysolutions.net/companies/covidien-lp/63d22b1b-1374-4530-ab2d-48293cfaee75

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