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•AbbVie Ltd•April 18, 2024

FDA 483 - AbbVie Ltd - April 18, 2024

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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.

Company
AbbVie Ltd
Inspection Date
April 18, 2024
Product Type
Drugs
Office
Division of Human and Animal Food Operations - West III
Person
  • Libia Lugo
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ID · 5b5d5729-ba72-422f-a406-f7a5a4a090cd

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