483
AbbVie LtdAbbVie Ltd – FDA 483, Apr 18, 2024
Record Details
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.
View Company Profile
ID · 5b5d5729-ba72-422f-a406-f7a5a4a090cd
Other documents for AbbVie Ltd
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.