# Abbvie Biotechnology Ltd. – FDA 483, Jun 10, 2026

Source: https://www.keypedia.com/records/483/abbvie-biotechnology-ltd/82189424-eaad-4d9f-b8f2-3ec9a752cbd0

> FDA 483 for Abbvie Biotechnology Ltd. on June 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbvie Biotechnology Ltd.
- Inspection Date: 2026-06-10
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: Abbvie Biotechnology Ltd. in Barceloneta, PR, a sterile drug manufacturer, received a Form 483 with three observations. The inspection revealed significant deficiencies in aseptic process control, including inadequate media fill challenges and airflow visualization studies. Additionally, the firm failed to maintain complete laboratory records and adhere to established environmental monitoring procedures, indicating systemic quality control issues.

## Related Documents

- [483 - 2023-10-30](https://www.keypedia.com/records/483/abbvie-biotechnology-ltd/fc6e7103-fba8-48a2-aaec-eae25e1f9e30) — date: October 30, 2023
- [EIR - 2019-03-25](https://www.keypedia.com/records/eir/abbvie-biotechnology-ltd/60b66384-af33-4ed5-93d8-e8d6f46a6c62) — date: March 25, 2019
- [483 - 2019-03-25](https://www.keypedia.com/records/483/abbvie-biotechnology-ltd/21216898-f0d2-4e1d-a352-c04132283cdb) — date: March 25, 2019
- [EIR - 2017-01-13](https://www.keypedia.com/records/eir/abbvie-biotechnology-ltd/b46b0168-1899-4d02-b119-b2104039df67) — date: January 13, 2017
- [483](https://www.keypedia.com/records/483/abbvie-biotechnology-ltd/b841e8d1-f95e-4ef1-bf9f-48c8f728cd44)

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)
- [Christian F. Gomez Lugo](https://www.keypedia.com/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)
- [Mabany Lizardi](https://www.keypedia.com/people/mabany-lizardi/adcca71c-e996-44e5-9827-d1aa2773e832)

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

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8