# FDA 483 - Abbott Laboratories Inc. - March 29, 2024

Source: https://www.globalkeysolutions.net/records/483/abbott-laboratories-inc/af83741c-4745-4a96-9860-37c5bc5eb43d

> FDA 483 for Abbott Laboratories Inc. on March 29, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Laboratories Inc.
- Inspection Date: 2024-03-29
- Product Type: other
- Office Name: Denver District Office
- Summary: Abbott Laboratories Inc. in Casa Grande, AZ, received a Form 483 citing significant issues in infant formula manufacturing. The inspection revealed a lack of adequate process controls to prevent microbial contamination, particularly Cronobacter sakazakii, stemming from environmental monitoring failures, persistent water leaks, and poor transition zone hygiene. Additionally, the firm failed to maintain sanitary building conditions and lacked proper equipment monitoring to prevent metal contamination in finished products.

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## Related Officers

- [Eric R. Holm](https://www.globalkeysolutions.net/people/eric-r-holm/3ef7df4a-e6e9-42df-99b7-741fbc8d9fae)
- [Investigator](https://www.globalkeysolutions.net/people/karen-m-labounty/66d6e00f-20e1-4c6b-a997-443db6cbfeee)
- [Investigator](https://www.globalkeysolutions.net/people/amy-l-mcintyre/713bba22-598e-4367-9b92-65848875b342)
- [Clair J Esquilin Austin](https://www.globalkeysolutions.net/people/clair-j-esquilin-austin/8094e632-6631-41ec-883d-0e0883be420c)
- [Kawshalya Pathiraja](https://www.globalkeysolutions.net/people/kawshalya-pathiraja/8a7471bb-a0a5-4653-b24c-5be0fa9359c0)

Company: https://www.globalkeysolutions.net/companies/abbott-laboratories-inc/7719b34b-6023-4fd5-8f3d-4c159984c675

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face