# FDA 483 - Abbott Laboratories - September 24, 2019

Source: https://www.keypedia.com/records/483/abbott-laboratories/58ecb2e4-0b47-4001-9c8a-caf28fa7836b

> FDA 483 for Abbott Laboratories on September 24, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Laboratories
- Inspection Date: 2019-09-24
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Abbott Nutrition in Sturgis, MI, from September 16-24, 2019, revealed a significant issue regarding quality control. The firm failed to adequately test representative samples of powdered infant formula at the final product stage to ensure required microbiological quality standards were met. This indicates a serious lapse in ensuring product safety before distribution.

## 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

- [Consumer Safety Officer](https://www.keypedia.com/people/dariusz-galezowski/afe749ae-1c27-428f-b321-12464fd084ad)
- [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