FDA 483 - Abbvie Biotechnology Ltd. - March 25, 2019
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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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ID · 21216898-f0d2-4e1d-a352-c04132283cdb