# FDA 483 - Abbott Diabetes Care, Inc. - December 04, 2017

Source: https://www.keypedia.com/records/483/abbott-diabetes-care-inc/5e5fee94-c995-44a4-896a-f44017b5bc8e

> FDA 483 for Abbott Diabetes Care, Inc. on December 04, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Diabetes Care, Inc.
- Inspection Date: 2017-12-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Abbott Diabetes Care, Inc. in Alameda, CA, revealed inadequate procedures for receiving, reviewing, and evaluating complaints. The firm failed to adequately investigate an MDR-related complaint for a FreeStyle Libre Pro Flash Glucose Monitoring System Sensor, specifically by not reviewing Device History Records or testing retained product. This indicates a deficiency in their complaint management process for medical devices.

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## Related Officers

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Company: https://www.keypedia.com/companies/abbott-diabetes-care-inc/bde5d1eb-44f0-4a7d-847b-6274f46dcbb7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b