483
Abbvie Biotechnology Ltd.Abbvie Biotechnology Ltd. – FDA 483, Jun 10, 2026
Record Details
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.
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ID · 82189424-eaad-4d9f-b8f2-3ec9a752cbd0
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