# FDA 483 - AbbVie Inc. - June 18, 2024

Source: https://www.keypedia.com/records/483/abbvie-inc/7e512946-7c93-4d23-9562-94c9c7dc0048

> FDA 483 for AbbVie Inc. on June 18, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AbbVie Inc.
- Inspection Date: 2024-06-18
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: AbbVie Inc. in North Chicago, IL, a sterile drug manufacturer, was cited for deficiencies in laboratory controls. The inspection revealed that the firm lacked scientifically sound justification for its Survanta stability testing program and failed to protect microbiology plates from desiccation during incubation. These issues indicate a failure to ensure the quality and purity of drug products and in-process materials.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/abbvie-inc/c35438c0-ba63-48cc-9220-b887563775b5)

## Related Officers

- [Program Expert ](https://www.keypedia.com/people/michele-l-obert/7ac8155e-cc5a-4e89-a885-c68ce69adb4e)
- [Michele L. Glendenning](https://www.keypedia.com/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.keypedia.com/companies/abbvie-inc/404ebab5-56a6-486d-bb01-be43a9478fad

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