# FDA 483 - Abbott Medical - August 02, 2019

Source: https://www.keypedia.com/records/483/abbott-medical/485be1aa-9f15-467f-9ad4-1739c25d4903

> FDA 483 for Abbott Medical on August 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Medical
- Inspection Date: 2019-08-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Abbott/St. Jude Medical Inc. in Sylmar, CA, a medical device manufacturer, was cited for three observations during an FDA inspection. The firm failed to adequately control non-conforming products, exhibited inadequate risk analysis for implanted devices, and did not report a significant field correction to the FDA. These issues relate to pacemakers and programmer software updates.

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## Related Officers

- [Nicole M Gillette](https://www.keypedia.com/people/nicole-m-gillette/70470546-1b8a-4e72-abee-547b25748d58)
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Company: https://www.keypedia.com/companies/abbott-medical/9609a880-3ad7-48ea-905b-9faaf9179e85

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6