# FDA 483 - Abbott - June 28, 2024

Source: https://www.globalkeysolutions.net/records/483/abbott/8b0ccfe2-c4a9-4369-9c8f-e59c50f30888

> FDA 483 for Abbott on June 28, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott
- Inspection Date: 2024-06-28
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Abbott in Plymouth, MN, identified significant deficiencies in its role as a sponsor-monitor for an investigational study. Observations included failures to ensure the timely return of investigational devices from non-compliant investigators and delays in recognizing and acting upon serious non-compliance. Additionally, the firm submitted incomplete and inaccurate annual progress reports to the FDA and IRBs, indicating concerns with clinical trial oversight and regulatory reporting.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)

Company: https://www.globalkeysolutions.net/companies/abbott/b7d5749c-5854-4f4a-ad2f-fd6002f0d9fe

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d