# FDA 483 - Abbott Vascular - May 03, 2023

Source: https://www.keypedia.com/records/483/abbott-vascular/5d54253a-6ece-4ab6-8317-6c616266e862

> FDA 483 for Abbott Vascular on May 03, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Vascular
- Inspection Date: 2023-05-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Abbott Vascular in Menlo Park, CA, from April 26 to May 3, 2023, revealed significant deficiencies in their quality system. The firm's procedures for rework and continued processing of nonconforming product were found to be inadequate. Specifically, these procedures failed to include provisions for evaluating the adverse effects of such processes on the final product.

## Related Officers

- [investigator](https://www.keypedia.com/people/elizabeth-a-dakan/f701338d-0484-431b-8bd5-9db442b5f079)

Company: https://www.keypedia.com/companies/abbott-vascular/70ec6b4d-9eb2-4e02-8e3f-666fd4df1027

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