# FDA 483 - Medtronic Xomed, Inc. - October 29, 2021

Source: https://www.keypedia.com/records/483/medtronic-xomed-inc/c5fc974e-0f65-4937-9bb1-e098a68f7e4b

> FDA 483 for Medtronic Xomed, Inc. on October 29, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Xomed, Inc.
- Inspection Date: 2021-10-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Medtronic Xomed, Inc. in Jacksonville, FL, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies across multiple quality system areas, including production process controls, corrective and preventive actions, complaint handling, non-conforming product control, and supplier management. These issues indicate a systemic failure to ensure device conformity, investigate failures, and maintain adequate quality oversight.

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Company: https://www.keypedia.com/companies/medtronic-xomed-inc/1309a87b-9fb3-4260-ba3a-8cb515b17fc4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6