# FDA 483 - Abbott Laboratories - September 24, 2021

Source: https://www.keypedia.com/records/483/abbott-laboratories/c5c430c3-e00d-46ae-97a4-7681512cbf2d

> FDA 483 for Abbott Laboratories on September 24, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Laboratories
- Inspection Date: 2021-09-24
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Abbott Nutrition's infant formula manufacturing facility in Sturgis, MI, revealed significant deficiencies. Observations included unsanitary building conditions with standing water and contaminated equipment, inadequate equipment installation and calibration, and poor personnel hygiene practices. Additionally, the firm failed to properly monitor and document critical processing parameters for thermal processing equipment.

## Related Documents

- [483 - 2022-03-18](https://www.keypedia.com/records/483/abbott-laboratories/cddf9d08-ba82-455c-bee1-930e7156412a)
- [483 - 2021-09-24](https://www.keypedia.com/records/483/abbott-laboratories/8b16aa80-6633-49a0-b838-01ef4cbb2522)
- [EIR - 2019-09-24](https://www.keypedia.com/records/eir/abbott-laboratories/6150f618-2491-46d1-8bf6-57b5ea8e46c4)
- [483 - 2019-09-24](https://www.keypedia.com/records/483/abbott-laboratories/e64c4569-8746-4564-82aa-a4286788acf6)
- [EIR - 2018-09-18](https://www.keypedia.com/records/eir/abbott-laboratories/a951bc37-0142-4427-b446-e72c3b9ac19b)

## Related Officers

- [Elizabeth P. Mayer](https://www.keypedia.com/people/elizabeth-p-mayer/aa5dbd87-75dd-4717-b141-32a76056bd08)
- [Investigator](https://www.keypedia.com/people/daniel-b-arrecis/d418d5a0-aa4c-4408-9f73-3fe668d97cdd)

Company: https://www.keypedia.com/companies/abbott-laboratories/e395ce4f-5eb4-41bf-9d1c-df73e573f136

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669