# FDA 483 - Abbvie Biotechnology Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/abbvie-biotechnology-ltd/b841e8d1-f95e-4ef1-bf9f-48c8f728cd44

> FDA 483 for Abbvie Biotechnology Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbvie Biotechnology Ltd.
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Abbvie Biotechnology LTD in Barceloneta, Puerto Rico, revealed significant deficiencies in quality control systems. The firm failed to adequately investigate and document consumer complaints for its Humira product, and laboratory investigations lacked sufficient supporting evidence. Additionally, procedures for inspecting raw materials and syringes were found to be inadequate, potentially impacting product quality.

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- [483 - 2023-10-30](https://www.globalkeysolutions.net/records/483/abbvie-biotechnology-ltd/fc6e7103-fba8-48a2-aaec-eae25e1f9e30)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6