# FDA 483 - Abbvie Biotechnology Ltd. - October 30, 2023

Source: https://www.keypedia.com/records/483/abbvie-biotechnology-ltd/fc6e7103-fba8-48a2-aaec-eae25e1f9e30

> FDA 483 for Abbvie Biotechnology Ltd. on October 30, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbvie Biotechnology Ltd.
- Inspection Date: 2023-10-30
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: An FDA inspection of Abbvie Biotechnology Ltd in Barceloneta, PR, from October 17-30, 2023, revealed deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm failed to establish and follow adequate written control procedures for handling unusual frequencies of process interventions during aseptic filling operations. This included a specific instance where an unexpected increase in a non-routine intervention was not assessed by the Quality Unit.

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## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

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

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