# FDA 483 - AbbVie Ltd - April 18, 2024

Source: https://www.keypedia.com/records/483/abbvie-ltd/5b5d5729-ba72-422f-a406-f7a5a4a090cd

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

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## Details

- Record Type: 483
- Company Name: AbbVie Ltd
- Inspection Date: 2024-04-18
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: AbbVie Ltd in Barceloneta, PR, was cited for significant quality control deficiencies during an FDA inspection from April 10-18, 2024. The firm failed to thoroughly investigate unexplained discrepancies, including microbial contamination in raw materials, cleaning validation samples, and pharmaceutical products like Synthroid tablets. Additionally, the microbiology laboratory lacked adequate controls for tracking microorganisms and establishing trends from environmental monitoring samples.

## Related Documents

- [483 - 2020-02-20](https://www.keypedia.com/records/483/abbvie-ltd/5c3978e3-1167-4486-ba55-390b0bdc4fd6)

## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.keypedia.com/companies/abbvie-ltd/b07cdd9b-e7d5-4b8b-b31d-3cc5dd0c3775

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab