# FDA 483 - Abbvie Biotechnology Ltd. - March 25, 2019

Source: https://www.keypedia.com/records/483/abbvie-biotechnology-ltd/21216898-f0d2-4e1d-a352-c04132283cdb

> FDA 483 for Abbvie Biotechnology Ltd. on March 25, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbvie Biotechnology Ltd.
- Inspection Date: 2019-03-25
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Abbvie Biotechnology Ltd. in Barceloneta, PR, a manufacturer of biologic drug substances and products, received a Form FDA 483 following an inspection from March 12-25, 2019. The inspection revealed significant deficiencies in process controls, complaint investigations, and quality oversight related to their Humira (adalimumab) pre-filled syringes, including issues with visible particles, clogged needles, and syringe leaks. The firm failed to adequately investigate and address these recurring product defects and consumer complaints.

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## Related Officers

- [Lilia M Lugo](https://www.keypedia.com/people/lilia-m-lugo/bd409997-f589-4d2d-b7ba-4b52f222e43e)

Company: https://www.keypedia.com/companies/abbvie-biotechnology-ltd/b438b15a-033c-469a-8973-66b6506bba41

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9