# FDA 483 - AbbVie Ltd - February 20, 2020

Source: https://www.keypedia.com/records/483/abbvie-ltd/5c3978e3-1167-4486-ba55-390b0bdc4fd6

> FDA 483 for AbbVie Ltd on February 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AbbVie Ltd
- Inspection Date: 2020-02-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: AbbVie LTD in Barceloneta, PR, was inspected from February 5-20, 2020, revealing significant deficiencies in production, process controls, cleaning procedures, and laboratory record-keeping. The inspection, which included a Pre-Approval Inspection for Elagolix/Estradiol/Norethindrone Acetate and a Post-Approval Inspection for Synthroid Tablets, identified a lack of adequate written procedures, incomplete batch records, insufficient cleaning validation, and incomplete laboratory data. These findings indicate a need for comprehensive improvements in the firm's quality systems to ensure drug product quality and purity.

## Related Documents

- [483 - 2024-04-18](https://www.keypedia.com/records/483/abbvie-ltd/5b5d5729-ba72-422f-a406-f7a5a4a090cd)

## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)
- [Ivis L. Negron Torres](https://www.keypedia.com/people/ivis-l-negron-torres/eb77f360-bb0b-4a13-a0da-b89c36ccaca9)

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-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6