FDA 483 - AbbVie Ltd - April 18, 2024

AbbVie Ltd in Barceloneta, PR, was cited for significant quality control deficiencies during an FDA inspection from April 10-18, 2024. The firm failed to thoroughly investigate unexplained discrepancies, including microbial contamination in raw materials, cleaning validation samples, and pharmaceutical products like Synthroid tablets. Additionally, the microbiology laboratory lacked adequate controls for tracking microorganisms and establishing trends from environmental monitoring samples.