# FDA 483 - Abbott Laboratories - December 16, 2022

Source: https://www.keypedia.com/records/483/abbott-laboratories/96cbe2a3-1d61-43c3-b821-a3ec56d70833

> FDA 483 for Abbott Laboratories on December 16, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Laboratories
- Inspection Date: 2022-12-16
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Abbott Laboratories dba Abbott Nutrition in Sturgis, MI, an infant formula manufacturer, revealed significant deficiencies in process controls, personnel hygiene, and facility sanitation. Inspectors noted a failure to adequately address water leaks and microbial contamination risks, improper gowning practices by employees, and unsanitary conditions including insects and debris. Additionally, the firm did not adhere to its own procedures for timely investigation and closure of serious adverse event consumer complaints, some of which involved Salmonella and death.

## 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

- [Roshni J. Patel](https://www.keypedia.com/people/roshni-j-patel/362827f6-562d-4780-b641-9c4bf0e1097b)
- [Darinka Galkowski](https://www.keypedia.com/people/darinka-galkowski/4e5374e2-9b88-44f0-95eb-d117c5826c74)
- [Brittany A. Mckenzie](https://www.keypedia.com/people/brittany-a-mckenzie/4f504ac7-a258-4144-b14c-19d9d139a549)
- [issuing_officer](https://www.keypedia.com/people/logan-m-ebeling/546c6a0d-664e-4189-b02b-2f8c1c05a640)
- [John N. Woodall](https://www.keypedia.com/people/john-n-woodall/60ba74fb-65b8-4195-a8bd-a9b576108246)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0