# FDA 483 - Covidien LP - November 18, 2022

Source: https://www.keypedia.com/records/483/covidien-lp/ae51e589-8bde-43b2-8468-9e8f1e32ebe3

> FDA 483 for Covidien LP on November 18, 2022. Product: devices. 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: devices
- Office Name: New England District Office
- Summary: During an inspection conducted from November 9 to November 18, 2022, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Covidien LP in Mansfield, MA. The inspection revealed deficiencies in the company's complaint handling procedures, a critical aspect of quality system regulations for medical device manufacturers. Specifically, the FDA observed that Covidien LP's procedures for receiving, reviewing, and evaluating product complaints lacked adequately established timeframes for initiation and completion. For instance, a review of complaints regarding Palindrome Chronic Hemodialysis Catheters, a device linked to a Class I recall, showed significant delays. Several complaints were not opened until 30 days or even up to four months after customer notification. Critically, one complaint, which was a reportable event to the FDA, was not submitted within the required 30-day timeframe. Additionally, other complaints, including some related to patient deaths, experienced delays of over 10 days before being opened. These observations indicate a need for Covidien LP to revise and implement clearer, uniformly enforced complaint handling procedures to ensure timely processing and reporting of product issues, adhering to the Federal Food, Drug, and Cosmetic Act and associated medical device quality system regulations. The company acknowledged the observation and promised to correct the identified deficiencies.

## Related Documents

- [WARNING_LETTER - 2012-02-09](https://www.keypedia.com/records/warning_letter/covidien-lp/a0cc9f70-5c1e-4d4d-a82f-7af430940235)
- [483 - 2022-11-18](https://www.keypedia.com/records/483/covidien-lp/563e8d37-a3fd-4c84-8b36-59678d5a131f)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/sunita-pandey-investigator/ddf84823-79ea-42d8-926a-8b857b8fcf28)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144